Interventive diagnostic device

ABSTRACT

Apparatus and methods are described for facilitating improving health of a user. In accordance with some applications, a first physiological variable, which is indicative of a voluntary action of the user, is received. A second physiological variable, which is not entirely under the direct voluntary control of the user, is received. Responsive to the first and second variables, the second physiological variable is changed in a desired manner, by using circuitry to direct the user to modify a parameter of the voluntary action, by generating an output signal. Other applications are also described.

The present application is a divisional application of U.S. patentapplication Ser. No. 12/427,183 filed Apr. 21, 2009 now U.S. Pat. No.8,183,453, which is a divisional of application No. 10/685,956 filed onOct. 15, 2003 (now U.S. Pat. No.: 7,717,858, issued May 18, 2010), whichis a divisional of application No. 09/611,304 filed on Jul. 6, 2000 (nowU.S. Pat. No. 6,662,032, issued Dec. 9, 2003), and which claims priorityfrom Israeli Patent Application 130818 filed Jul. 6, 1999 andincorporates the same by reference.

FIELD OF THE INVENTION

The present invention relates generally to medical devices, andspecifically to treatment and diagnostic devices which provide feedbackto a user regarding a physiological variable of the user.

BACKGROUND OF THE INVENTION

Devices which measure a physiological variable of a user and which thenprovide feedback to the user for the purpose of modifying the variableare well known in the art. U.S. Pat. Nos. 5,076,281, and 5,800,337, tothe present inventor, which are incorporated herein by reference, bothdescribe methods and devices for modifying biorhythmic activity bymeasuring one or more variables of a user. The patents describe thegeneration of a stimulus which is provided to the user, so as to changethe biorhythmic activity of the user in a way that is related to themonitored biorhythmic activity.

U.S. Pat. No. 5,423,328, to the present inventor, which is alsoincorporated herein by reference, describes a stress-detecting devicefor monitoring respiration, and, in particular, a method for detectingand monitoring circumferential changes in the chest or abdomen of a userresulting from breathing. U.S. Pat. No. 4,580,574, to the presentinventor, which is also incorporated herein by reference, describes amethod for non-invasively monitoring properties of living tissue.

An abstract entitled, “Repeated blood pressure measurements may probedirectly an arterial property,” American Journal of Hypertension (April,2000); 13(4), part 2: 190A, by B. Gavish, which is incorporated hereinby reference, proposes that the slope of a line relating multiplesystolic and diastolic blood pressure measurements is aphysiologically-meaningful parameter.

An article entitled, “Challenges facing 3-D audio display design formultimedia,” Journal of the Acoustical Society of America (1999); J105:1357, by D. R. Begault, which is incorporated herein by reference,describes the production and psychophysiological implications of 3-Dsound, which enables listeners to perceive the direction of a soundsource in three dimensions. Another article, entitled, “Localizationusing nonindividualized head-related transfer functions,” by Wenzel etal., Journal of the Acoustical Society of America (July, 1993); 94(1),pp. 222-234, which is incorporated herein by reference, describes thesynthesis of 3-D sound, so as to enable listeners to perceive the 3-Ddirection and localization of a virtual sound source. In addition, acassette distributed by NASA/Ames Research Center, entitled,“Demonstration of 3-D auditory display,” allows a listener using anormal cassette player and standard earphones to experience thethree-dimensional effect.

Other articles of interest include:

(a) an article by Cooke et al., entitled, “Controlled breathingprotocols probe human autonomic cardiovascular rhythms,” AmericanJournal of Physiology, (1998); 274:H709-H718,

(b) an article by Pitzalis et al., entitled, “Effect of respiratory rateon the relationship between RR interval and systolic blood pressurefluctuations: a frequency-dependent phenomenon,” Cardiovascular Research(1998); 38:332-339,

(c) an article by Bernardi et al., entitled, “Effect of breathing rateon oxygen saturation and exercise performance in chronic heart failure,”The Lancet (May 2, 1998); 351:1308-1311,

(d) an article by Mortara et al., entitled, “Abnormal awake respiratorypatterns are common in chronic heart failure and may prevent evaluationof autonomic tone by measures of heart rate variability,” Circulation(Jul. 1, 1997); 96:246-252,

(e) an article by La Rovere et al., entitled, “Baroreflex sensitivityand heart-rate variability in prediction of total cardiac mortalityafter myocardial infarction,” The Lancet (Feb. 14, 1998); 351:478-484,and

(f) an article by Gimondo and Mirk, entitled, “A new method forevaluating small intestinal motility using duplex Doppler sonography,”AJR American Journal of Roentgenology (January, 1997); 168(1):187-192.

All of these articles are incorporated herein by reference.

Devices which are at least partially operated remotely are also known inthe art. U.S. Pat. No. 4,102,332, to Gessman, which is incorporatedherein by reference, describes a device for remote telephonicresuscitation. The device includes an electrocardiograph and adefibrillator which are carried by a user with a known history ofcardiac symptoms, and which may be used to diagnose and treat acutecardiac symptoms. In order to facilitate the diagnosis and treatment,the device may be connected to a telephone line, so that a remotephysician may make the diagnosis and perform the treatment.

U.S. Pat. No. 4,195,626, to Schweizer, which is incorporated herein byreference, describes a biofeedback chamber for applying audible, visualelectrical or tactile stimuli to a subject according to a rhythmicpattern. The subject's reactions are measured, analyzed and used tocontrol the stimuli.

U.S. Pat. No. 5,782,878, to Morgan, which is incorporated herein byreference, describes a system including an external defibrillator, adefibrillator communicator, and a communication network. In order toperform a defibrillation, information is transmitted back and forthbetween a patient and a communication station.

U.S. Pat. No. 5,794,615, to Estes, which is incorporated herein byreference, describes a system for treatment of congestive heart failure.The patent describes controlling the flow rate of a pressurized gasdelivered to a patient during the two phases of the respiratory cycleindependently. The system may be fully automated responsive to feedbackprovided by a flow sensor that determines the estimated patient flowrate.

U.S. Pat. No. 5,678,571, to Brown, which is incorporated herein byreference, describes a method for treating a medical condition in apatient comprising choosing a psychological strategy for treating themedical condition, and then encoding electronic instructions for aninteractive video game. The game implements the psychological strategy,and loads the electronic instructions into a microprocessor-based unitequipped with a display for displaying the video game. The game containsscoring instructions to quantitatively analyze the medical condition ofthe patient, counseling instructions and self-care instructions. Thevideo game can be used in conjunction with a physiological variablemeasuring device connected to the microprocessor-based unit.

U.S. Pat. No. 5,752,509, to Lachmann, et al. describes a system forartificially ventilating a patient. The ventilation system has a gasdelivery unit for delivering controllable inspiration pulses to apatient, a monitoring unit for measuring at least one parameter relatedto the function of the circulatory system, such as a blood gas analyzer,and a control unit for determining an optimal peak inspiratory pressureand pressure amplitude for the inspiration pulse, based on the measuredcirculatory system parameter.

Descriptions of respiratory monitoring apparatus which assesscapacitance are found in U.S. Pat. No. 5,485,850 to Dietz, U.S. Pat. No.4,033,332 to Hardway et al, U.S. Pat. No. 4,381,788 to Douglas, U.S.Pat. No. 4,474,185 to Diamond, and in U.S. Pat. Nos. 5,367,292,5,070,321, and 5,052,400, all of which are incorporated herein byreference.

U.S. Pat. No. 5,690,691 to Chen, et al., which is incorporated herein byreference, describes a portable or implantable gastric pacemaker, whichincludes multiple electrodes that are positioned on an organ in thegastrointestinal (GI) tract, so as to deliver electrical stimulation topace the peristaltic movement of material through the GI tract.

U.S. Pat. Nos. 5,590,282 and 4,526,078, which are incorporated herein byreference, describe techniques for causing a computer to compose music.

U.S. Pat. No. 4,883,067 to Knispel et al., which is incorporated hereinby reference, describes a method for translating a subject'selectroencephalogram into music, so as to induce and control variouspsychological and physiological states of the subject.

U.S. Pat. No. 4,798,538 to Yagi, which is incorporated herein byreference, describes an abdominal respiration training system. The stateof the abdominal respiration of a person is measured by a sensorattached to the abdominal region, and the detected breath pattern iscompared with an ideal breath pattern.

SUMMARY OF THE INVENTION

It is an object of some aspects of the present invention to providemethods and apparatus which enable a user to improve a physiologicalvariable of the user.

It is a further object of some aspects of the present invention toprovide methods and apparatus which convey a stimulus to a user so as toimprove a physiological variable of the user.

It is yet a further object of some aspects of the present invention toprovide remotely-mediated methods and apparatus which enable a user toimprove a physiological variable of the user.

It is an additional object of some aspects of the present invention toprovide remotely-mediated methods and apparatus which enable a user tomodify physiological variables to improve health or manage a specificdisease.

In preferred embodiments of the present invention, aninterventive-diagnostic system comprises a local computing device at alocal site, which applies an intervention to a user at the site andreceives one or more input signals from one or more sensors attached tothe user. The input signals are indicative of a physiological conditionof the user. The local device makes a preliminary analysis of the inputsignals, thereby generating a set of analyzed data, and typicallymodifies a subsequent intervention responsive to the analyzed data. Theset of analyzed data and/or some or all of the input signals aretransmitted as data to a remote facility for further analysis. Theremote facility comprises a program operator, optionally using acomputer. The program operator makes a further analysis of the datareceived, and transmits a result of the analysis back to the localdevice and/or to the user. The local device uses the result from theremote facility and the input signals to modify a subsequentintervention which is applied to the user.

Preferably, the input signals and the analysis thereof made by the localdevice are stored by the device in a data logger, typically comprisingan electronic memory and/or a permanent storage medium. Some or all ofthe contents of the data logger are preferably transmittedintermittently, on-line, to the remote facility for processing.Typically, the stored data are utilized in combination with the inputsignals to generate the preliminary analysis. Additionally, by examiningdata stored in the data logger from several sessions, trends can becalculated by the device or at the remote facility to evaluate thesuccess of a particular intervention strategy. Subsequently, eitheron-line or off-line, the intervention strategy may be changed responsiveto the evaluation.

Typically, the further analysis performed by the program operatorcomprises activities which would be difficult or impossible to performat the local site. The result of the analysis may comprise a directresponse to the user, or a communication between computing devices. Forexample, the program operator may provide help to the user for operatingthe local device. Alternatively, the program operator and/or thecomputer at the remote facility may transmit the result directly to thelocal device, for example, in order to change a characteristic, settingor operational mode of the device. For some applications, a humanprogram operator is not necessary, and the computer at the remotefacility automatically performs the analysis.

An “intervention” is to be understood in the disclosure and in theclaims as a generation of a stimulus intended to modify one or morephysiological variables of a user. For example, the interventiontransmitted to the user may comprise an intelligible input stimulus,such as a sound pattern and/or dynamic graphical pattern, which isgenerated according to one or more predefined programs resident withinthe local device. The stimulus is typically intended to modify breathingof the user, for example, by training the user to initiate a newbreathing pattern. Most preferably, the intervention is one which isknown to have a positive effect on aspects of one or more of the user'sphysiological systems, such as the cardiovascular, pulmonary, and/orneurological systems.

The local device and/or the remote facility are also able to generate a“diagnosis” responsive to a physiological variable of the user. Adiagnosis is to be understood in the disclosure and in the claims as thegeneration of an evaluation responsive to one or more physiologicalvariables of the user, which evaluation may be monitored withoutmodifying the physiological variables.

The combination of a local device and a remote facility operatingtogether to provide intervention and diagnosis significantly enhancesthe ability of the local device to generate an intervention whichbenefits the user. Furthermore, the combination enables the remotefacility to follow effects, such as changes in diagnosis, generated bythe intervention and to interact with the local device and/or the userin order to give appropriate further feedback as appropriate.

Wellness and disease-management programs are one of the goals of modernhealthcare systems. These are addressed in preferred embodiments of thepresent invention, in which the interventive-diagnostic system isoperated over an extended period of time, on the order of months, andprogress of the user is followed by the remote facility during theperiod. Most preferably, a plurality of programs are stored within thelocal computing device, which programs comprise a sequence of modes ofdevice operation which are followed by the user during the period.During the extended period, the remote facility monitors that the useris correctly adhering to a particular program, provides help asappropriate, and obtains data relating to the user's progress.

In some preferred embodiments of the present invention, the stimulusprovided to the user is in the form of a game, and the parameters of thegame are altered so that playing the game induces the user to modify thephysiological variable. Having a stimulus in the form of a game, mostpreferably an audiovisual game, encourages users who are children toactively participate in a therapeutic intervention process. For example,children with pulmonary or motor-related neurological disease, such asasthma or hyperactivity, may be benefited by use of these embodiments ofthe invention.

In some preferred embodiments of the present invention, the local deviceis provided to the user from the remote facility, or from some otherfacility, for an evaluation period, during which period the useroperates the system as described above. On completion of the evaluationperiod, the user is able to return the device to one of the facilities,or continue to use the device after a payment has been received by oneof the facilities. Alternatively or additionally, the local device isgiven at no charge to a receiver, and is enabled to exchange data withthe remote operator, as described hereinabove, responsive to regularpayments to the remote facility.

There is therefore provided, in accordance with a preferred embodimentof the present invention, a method for inducing a modification of aphysiological variable of a user, including:

applying an intervention via a device to the user responsive to a set ofone or more intervention parameters;

measuring a physiological variable responsive to the intervention;

transmitting a signal responsive to the physiological variable to aremote facility for processing;

receiving a reply from the remote facility responsive to the signal; and

applying the intervention via the device to the user responsive to thereply.

Preferably, the physiological variable is a variable representative of abiorhythmic activity of the user, and is changed as a direct consequenceof the intervention. Further preferably, the intervention includesinstructing the user to voluntarily change the physiological variable,directly or indirectly, for example, by modifying a parameter of theuser's breathing, or by affecting blood flow responsive to respirationand/or respiratory movements.

Preferably, transmitting the signal includes connecting the device tothe remote facility via a distributed network or via a directcommunication link.

In a preferred embodiment, the device and the remote facility includerespective industry-standard computers, operating respective programs.

Preferably, applying the intervention includes providing an intelligiblesensory stimulus to the user.

Further preferably, transmitting the signal and receiving the replyinclude communicating a verbal message or transmitting and/or receivinga set of data.

Still further preferably, the device includes a comparator whichcompares a current physiological state of the user to a previousphysiological state of the user, in order to determine a change in thephysiological state responsive to the intervention.

Still further preferably, measuring the physiological variable includesgenerating a diagnosis and modifying the set of one or more interventionparameters responsive to the diagnosis.

In a preferred embodiment, the intervention includes a routineintervention, applied to the user at generally regular intervals, forexample, in a non-emergency setting.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for inducing a modification of aphysiological variable of a user, including:

providing an electronic game having a game parameter, the game to beplayed by the user;

applying an intervention via the game to the user responsive to the gameparameter;

measuring a physiological variable responsive to the intervention; and

modifying the game parameter responsive to the measured physiologicalvariable.

Preferably, providing the electronic game includes:

connecting the game to a remote facility;

transmitting the game parameter to the remote facility, and

transmitting the physiological variable to the remote facility.

In a preferred embodiment, connecting the game to the remote facilityincludes receiving a response from the remote facility for the purposeof modifying the game parameter. Alternatively or additionally, anotheruser operates the method at the remote facility.

Preferably, the physiological variable is changed as an indirectconsequence of the intervention. In a preferred embodiment, thephysiological variable includes an indication of blood oxygenation,cardiac electrical state, respiration or blood pressure.

In a preferred embodiment, the user has congestive heart failure,asthma, chronic obstructive pulmonary disease, hypertension, or cysticfibrosis. Alternatively, the user is generally healthy, and uses aspectsof the present invention in order to obtain psychological stress-reliefand/or relaxation, or for purposes of muscle re-education, athletictraining, or entertainment. For some applications, measuring thephysiological variable includes receiving a sound responsive torespiratory activity, such as wheezing.

Alternatively or additionally, measuring the physiological variableincludes receiving an indication of microvascular blood flow and/or ofthe stiffness of at least one blood vessel.

There is further provided, in accordance with a preferred embodiment ofthe present invention, a method for modifying a physiological variableof a user, including:

providing the user with an interventional device capable of modifyingthe variable responsive to an input from a remote facility;

enabling the device to operate during a time-limited period; and

enabling the device to operate after the time-limited period, responsiveto a receipt of payment.

Preferably, providing the user with the interventional device includesfacilitating the user and the remote facility to enter into an agreementregarding operation of the device. Typically, the receipt of paymentincludes a transfer of funds to the remote facility.

There is still further provided, in accordance with a preferredembodiment of the present invention, a method for enabling anintervention, including:

receiving a signal corresponding to a measured physiological variable ofa remote user, the physiological variable having been measuredresponsive to a first intervention via a device; and

transmitting a reply responsive to the signal, to modify aspects of asecond intervention applied via the device.

Preferably, receiving the signal includes generating a diagnosisresponsive to the measured physiological variable of the remote user.

There is additionally provided, in accordance with a preferredembodiment of the present invention, apparatus for inducing amodification of a physiological variable of a user, including:

a sensor, which generates a measure of the physiological variable of theuser;

a stimulation unit, which provides an intervention to the user; and

a device, which is coupled to the sensor and the stimulation unit, andwhich:

determines a set of one or more intervention parameters responsive tothe measure of the physiological variable;

operates the stimulation unit responsive to the set of one or moreintervention parameters;

transmits a signal responsive to the physiological variable to a remotefacility for processing;

receives a reply from the remote facility responsive to the signal; and

applies the intervention via the stimulation unit to the user responsiveto the reply.

Preferably, the device includes a comparator and a memory, wherein anindication of a physiological state of the user is intermittently storedin the memory, and wherein the comparator compares a current indicationof the physiological state to a previous indication of the physiologicalstate, in order to determine a change in the user's physiological state.

In a preferred embodiment, the stimulation unit includes anindustry-standard computer.

There is yet additionally provided, in accordance with a preferredembodiment of the present invention, apparatus for inducing amodification of a physiological variable of a user, including:

an electronic game to be played by the user, the game applying anintervention to the user responsive to a game parameter;

a sensor, which measures a physiological variable responsive to playingof the game; and

a processor which modifies the game parameter responsive to the measuredphysiological variable.

Preferably, the processor is located at a remote facility. In apreferred embodiment, another user plays a similar game at the remotefacility.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for enabling an intervention, including:

a receiver, located at a local facility, which receives a signalcorresponding to a measured physiological variable of a remote user, thephysiological variable having been measured responsive to a firstintervention via a device; and

a transmitter, located at the local facility, which transmits a replyresponsive to the signal, to modify aspects of a subsequent interventionapplied via the device.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for generating music, including:

receiving a rhythm signal corresponding to a rhythm of a cyclicphysiological activity of a user, the physiological activity havingfirst and second activity phases thereof;

analyzing the rhythm signal to determine first and second durationsthereof, respectively corresponding to the first and second activityphases;

determining first and second new durations responsive to desired changesof the first and second durations of the rhythm signal;

generating responsive to the new durations a music signal forpresentation to the user, the music signal having first and second musicphases thereof respectively corresponding to the first and secondactivity phases, a duration of each of the music phases expressible asbeing approximately equal to an integer multiple of a base duration, theinteger multiple being less than or equal to four; and

directing the user to modify durations of the first and second activityphases responsive to the respective durations of the first and secondmusic phases.

Alternatively or additionally, generating the music signal includessetting the duration of one of the music phases to be approximatelyequal to an integer multiple of the other one of the music phases.

Alternatively or additionally, directing the user to modify thedurations includes directing the user to attempt to perform the firstand second activity phases of the physiological activity such that therespective durations thereof are substantially equal to the durations ofthe first and second music phases.

Alternatively or additionally, receiving the rhythm signal includesreceiving a motion signal corresponding to an activity of the userselected from the list consisting of: walking, jogging, and running.

Alternatively or additionally, receiving the rhythm signal includesreceiving a respiration signal corresponding to respiration of the user.

Alternatively or additionally, receiving the breathing signal includesreceiving an indication of a timing characteristic of inspiratory andexpiratory phases of the respiration.

Alternatively or additionally, determining the new durations includesdetermining the new durations responsive to a vasomotor frequency of theuser.

Alternatively or additionally, the method includes measuring acardiovascular variable of the user and determining the vasomotorfrequency responsive thereto.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for generating music, including:

receiving a rhythm signal corresponding to a rhythm of a cyclicphysiological activity of a user, the physiological activity havingfirst and second activity phases thereof;

analyzing the rhythm signal to determine first and second durationsthereof, respectively corresponding to the first and second activityphases;

determining first and second new durations responsive to desired changesof the first and second durations of the rhythm signal;

generating responsive to the new durations a music signal forpresentation to the user, the music signal having first and second musicphases thereof respectively corresponding to the first and secondactivity phases, a duration of one of the music phases beingapproximately equal to an integer multiple of a duration of the otherone of the music phases; and

directing the user to modify durations of the first and second activityphases responsive to the respective durations of the first and secondmusic phases.

Alternatively or additionally, directing the user to modify thedurations includes directing the user to attempt to perform the firstand second activity phases of the physiological activity such that therespective durations thereof are substantially equal to the durations ofthe first and second music phases.

Alternatively or additionally, receiving the rhythm signal includesreceiving a respiration signal corresponding to respiration of the user.

Alternatively or additionally, determining the new durations includesdetermining the new durations responsive to a vasomotor frequency of theuser.

Alternatively or additionally, the method includes measuring acardiovascular variable of the user and determining the vasomotorfrequency responsive thereto.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for generating music, including:

receiving a rhythmic physiological pattern corresponding to a rhythm ofa physiological activity of a user;

analyzing the rhythmic physiological pattern to determine an actualactivity pattern thereof;

determining a new activity pattern responsive to a desired change of theactual activity pattern;

generating a music signal for presentation to the user, the music signalhaving two or more sets of notes, at least one of the sets of noteshaving a rhythmic characteristic corresponding to the new activitypattern; and

directing the user to modify the rhythm of the physiological activityresponsive to the music signal.

Alternatively or additionally, directing the user includes directing theuser to modify the rhythm of the physiological activity to correspond tothe rhythmic characteristic.

Alternatively or additionally, directing the user includes playing atleast part of the music signal.

Alternatively or additionally, directing the user includes outputting avocal message.

Alternatively or additionally, receiving the rhythmic physiologicalpattern includes receiving a motion signal corresponding to an activityof the user selected from the list consisting of: walking, jogging, andrunning.

Alternatively or additionally, generating the music signal includesvarying a characteristic of the notes in one of the sets responsive toat least one of: the actual activity pattern and the new activitypattern.

Alternatively or additionally, varying the characteristic includesvarying a characteristic of an envelope parameter of the notes.

Alternatively or additionally, generating the music signal includesgenerating the signal in accordance with the Musical Instrument DigitalInterface (MIDI) standard.

Alternatively or additionally, generating the music signal includesdefining at least two of the sets of notes as being in distinct layers.

Alternatively or additionally, receiving the rhythmic physiologicalpattern includes receiving a respiration signal corresponding torespiration of the user.

Alternatively or additionally, receiving the breathing signal includesreceiving an indication of a timing characteristic of inspiratory andexpiratory phases of the respiration.

Alternatively or additionally, determining the new activitypattern'includes determining the new activity pattern responsive to avasomotor frequency of the user.

Alternatively or additionally, the method includes measuring acardiovascular variable of the user and determining the vasomotorfrequency responsive thereto.

Alternatively or additionally, generating the music signal includes:

substantially not outputting the notes in at least one of the sets whenthe new activity pattern is characterized by a first rate; and

outputting the notes in the at least one of the sets when the newactivity pattern is characterized by a second rate, which is slower thanthe first rate.

Alternatively or additionally, generating the music signal includes:

substantially not outputting the notes in a second one of the sets whenthe new activity pattern is characterized by the second rate; and

outputting the notes in the second set when the new activity pattern ischaracterized by a third rate, which is slower than the second rate.

Alternatively or additionally, generating the music signal includessubstantially not outputting the notes in the at least one of the setswhen the new activity pattern is characterized by the third rate.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for generating music, including:

receiving a rhythm signal corresponding to a rhythm of a cyclicphysiological activity of a user;

analyzing the rhythm signal to determine a pattern thereof;

determining a new pattern responsive to a desired change of the patternof the rhythm signal;

generating, responsive to the new pattern, a music signal forpresentation to the user;

determining, responsive to a characteristic of the new pattern, a set ofmusic layers to include in the music signal, the layers having notes,such that the notes of one of the layers are played at a generallyfaster rate than the notes of another one of the layers; and

directing the user to modify the rhythm of the physiological activityresponsive to the music signal.

Alternatively or additionally, analyzing the rhythm signal to determinethe pattern thereof includes analyzing the rhythm signal to determine acharacteristic frequency thereof, and determining the new patternincludes determining a new frequency responsive to a desired change ofthe frequency of the rhythm signal.

Alternatively or additionally, receiving the rhythm signal includesreceiving a respiration signal corresponding to respiration of the user.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for facilitating improving health of auser, including:

a first sensor, adapted to measure a first physiological variable, whichis indicative of a voluntary action of the user;

a second sensor, adapted to measure a second physiological variable,which is not entirely under the direct voluntary control of the user;and

circuitry, adapted to receive respective first and second sensor signalsfrom the first and second sensors, and, responsive thereto, to generatean output signal which directs the user to modify a parameter of thevoluntary action.

Alternatively or additionally, the circuitry is adapted to generate theoutput signal such that if the user modifies a parameter of thevoluntary action responsive to the output signal, then the secondphysiological variable will be changed in a desired manner.

Alternatively or additionally, the circuitry is adapted to: (a) generatethe output signal to direct the user to modify the parameter of thevoluntary action, (b) identify an aspect of the first sensor signalindicative of the user having modified the parameter to a desiredextent, and (c) responsive to identifying the aspect of the first sensorsignal, generate a new output signal, to direct the user to furthermodify the parameter of the voluntary action.

Alternatively or additionally, the circuitry is adapted to generate theoutput signal to direct the user to modify the parameter of thevoluntary action, so as to facilitate an improvement in congestive heartfailure of the user.

Alternatively or additionally, the circuitry is adapted to generate theoutput signal to direct the user to modify the parameter of thevoluntary action, so as to facilitate treatment of a blood pressuredisorder of the user.

Alternatively or additionally, the circuitry is adapted to generate theoutput signal to direct the user to modify the parameter of thevoluntary action, so as to facilitate an improvement in asthma of theuser.

Alternatively or additionally, the circuitry is adapted to generate theoutput signal to direct the user to modify the parameter of thevoluntary action, so as to facilitate an improvement in cystic fibrosisof the user.

Alternatively or additionally, the circuitry is adapted to generate theoutput signal to direct the user to modify the parameter of thevoluntary action, so as to facilitate an increase in mechanicalcompliance of arteries of the user.

Alternatively or additionally, the circuitry is adapted to generate theoutput signal to direct the user to modify the parameter of thevoluntary action, so as to facilitate an increase in oxygenation oftissue of the user.

Alternatively or additionally, the circuitry is adapted to generate theoutput signal to direct the user to modify the parameter of thevoluntary action, so as to facilitate weaning the user from a mechanicalventilator, reducing a duration of a post-surgery recover period of theuser, reducing excessive sympathetic activity of the user, amodification of peristaltic activity of the user, a modification ofvasomotor activity of the user, an increase of heart rate variability ofthe user, an increase of venous return to a heart of the user, areduction of vasomotor tone of the user, a reduction of airwayresistance of the user, an increase of endurance of an expiratory muscleof the user, an increase of blood flow in capillaries of the user,and/or a reduction of pain experienced by the user.

Alternatively or additionally, the apparatus includes a speaker, whereinthe circuitry is adapted to drive the speaker to generate music, so asto direct the user to modify the parameter of the voluntary action.

Alternatively or additionally, the apparatus includes a speaker, whereinthe circuitry is adapted to drive the speaker to output natural sounds,so as to direct the user to modify the parameter of the voluntaryaction.

Alternatively or additionally, the apparatus includes a screen, whereinthe circuitry is adapted to drive the screen to display one or morepatterns corresponding to the output signal, so as to direct the user tomodify the parameter of the voluntary action.

Alternatively or additionally, the second sensor includes a bloodpressure sensor, a photoplethysmographic sensor, a blood oximeter, anelectrocardiographic sensor, and/or an electroencephalographic sensor.

Alternatively or additionally, the second sensor is adapted to measureheart rate of the user.

Alternatively or additionally, the second sensor includes an ultrasonicsensor, adapted to measure a cardiovascular variable.

Alternatively or additionally, the second sensor is adapted to measure apulsatile change of volume of blood in an artery of the user, anon-pulsatile change of volume of blood in an artery of the user, apulsatile change of volume of blood in tissue of the user, and/or anon-pulsatile change of volume of blood in tissue of the user.

Alternatively or additionally, the second sensor is adapted tonon-invasively measure blood viscosity of the user.

Alternatively or additionally, the second sensor is adapted to measurethe second physiological variable so as to facilitate a determination ofa characteristic of peristalsis of the user.

Alternatively or additionally, the second sensor is adapted to measurethe second physiological variable so as to facilitate a determination ofarterial compliance of the user, pulse wave velocity of blood in bloodvessels of the user, and/or a vasomotor frequency of the user.

Alternatively or additionally, the circuitry is adapted to set afrequency of the output signal responsive to the vasomotor frequency.

Alternatively or additionally, the first sensor includes a motionsensor.

Alternatively or additionally, the first sensor is adapted to be coupledto a limb of the user and to generate the first sensor signal responsiveto motion of the limb.

Alternatively or additionally, the first sensor is adapted to measure acyclic physiological variable of the user and to generate the firstsensor signal responsive thereto, and wherein the circuitry is adaptedto generate the output signal responsive to a desired change in afrequency of the cyclic physiological variable.

Alternatively or additionally, the first sensor includes a respirationsensor.

Alternatively or additionally, the apparatus includes a belt adapted tobe placed around a torso of the user, wherein the respiration sensor isadapted to generate the first sensor signal responsive to a change incircumference of the torso.

Alternatively or additionally, the respiration sensor is adapted tomeasure a characteristic of the user's respiration so as to facilitate adetermination of airway resistance of the user.

Alternatively or additionally, the respiration sensor is adapted tomeasure a characteristic of the user's respiration so as to facilitate adetermination of a mechanical load against which the user breathes.

Alternatively or additionally, the circuitry is adapted to: (a)determine, responsive to the first signal, a current value of anExpiratory:Inspiratory (E:I) ratio of the user, (b) determine a desiredfinal value of the E:I ratio, and (c) generate the output signal so asto direct the user to vary the user's E:I ratio from the current valuethereof, through one or more intermediate values thereof, to the desiredfinal value.

Alternatively or additionally, the circuitry is adapted to: (a)determine, responsive to the first signal, a current respiration rate ofthe user, (b) determine a desired final respiration rate, and (c)generate the output signal so as to direct the user to vary the user'srespiration rate from the current value thereof, through one or moreintermediate values thereof, to the desired final value.

Alternatively or additionally, the circuitry is adapted to: (a)determine, responsive to the first signal, a current value of anExpiratory:Inspiratory (E:I) ratio of the user, (b) determine a desiredfinal value of the E:I ratio, and (c) generate the output signal so asto direct the user to vary the user's E:I ratio from the current valuethereof, through one or more intermediate values thereof, to the desiredfinal value, at generally the same time as directing the user to varythe respiration rate.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for facilitating improving health of auser, including a stimulator, which is adapted to stimulate a portion ofa body of the user at a stimulation rate between about 0.05 Hz and 0.15Hz.

Preferably, the stimulator includes a pressure applicator, adapted toapply mechanical pressure, which varies at the stimulation rate, to theportion of the body.

Alternatively or additionally, the stimulator includes an electrode,adapted to apply electrical energy, which varies at the stimulationrate, to the portion of the body.

Alternatively or additionally, the stimulator includes a magnetic fieldgenerator, adapted to apply a magnetic field, which varies at thestimulation rate, to the portion of the body.

Alternatively or additionally, the stimulator includes atemperature-modifying unit, adapted to apply at the stimulation rate tothe portion of the body at least one of: heating and cooling.

Alternatively or additionally, the stimulator includes anelectromagnetic radiation emitter, adapted to apply electromagneticradiation, which varies at the stimulation rate, to the portion of thebody.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for facilitating improving health of auser, including:

a sensor, adapted to measure a physiological variable of the user and togenerate a sensor signal responsive thereto;

a processor, adapted to receive the sensor signal and to determine,responsive thereto, a frequency of variation of a cardiovascularvariable of the user that lies between about 0.05 Hz and 0.15 Hz; and

a stimulator, adapted to stimulate the user at the determined frequency.

Preferably, the sensor includes a first sensor, wherein the apparatusincludes a second sensor, adapted to measure a second physiologicalvariable and to convey to the processor a second sensor signalresponsive thereto, and wherein the processor is adapted to drive thestimulator to stimulate the user so as to obtain a desired value of thesecond sensor signal.

Alternatively or additionally, the stimulator includes a pressureapplicator, adapted to apply to the user mechanical pressure, whichvaries at the determined frequency.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for facilitating improving health of auser, including:

a sensor, adapted to measure a physiological variable of the user and togenerate a sensor signal responsive thereto; and

circuitry, adapted to receive the sensor signal and to generateresponsive thereto, for presentation to the user, two or more acousticsignals which are configured so as to create a spatial sound effect.

Preferably, the circuitry is adapted to configure the acoustic signalsso as to create a stereo sound effect.

Alternatively or additionally, the circuitry is adapted to configure theacoustic signals so as to create a three-dimensional sound effect.

Alternatively or additionally, the sensor includes a first sensor,adapted to measure a first physiological variable, which is indicativeof a voluntary action of the user, wherein the apparatus includes asecond sensor, adapted to measure a second physiological variable, whichis not entirely under the direct voluntary control of the user, andwherein the circuitry is adapted to respective first and second sensorsignals from the first and second sensors and, responsive thereto, togenerate the acoustic signals, so as to direct the user to modify aparameter of the voluntary action.

Alternatively or additionally, the circuitry is adapted to generate theacoustic signals such that an aspect of the spatial effect, selectedfrom the list consisting of: a vertical aspect and a horizontal aspect,corresponds to the parameter of the voluntary action.

Alternatively or additionally, the circuitry is adapted to generate theacoustic signals such that (a) a first sound generated responsivethereto is perceived by the user as coming from a first location andcorresponds to a direction to the user to exhale, and (b) a second soundgenerated responsive to the acoustic signals is perceived by the user ascoming from a second location which is higher than the first location,the second sound corresponding to a direction to the user to inhale.

Alternatively or additionally, the circuitry is adapted to generate theacoustic signals such that sounds generated responsive thereto, whichare perceived by the user as coming from left and right sides of theuser, correspond to respective directions to the user to move respectiveleft and right legs of the user.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for measuring blood pressure of a user,including:

a blood pressure sensor, adapted to take first and second blood pressuremeasurements and to generate respective first and second blood pressuresignals responsive to the measurements, a time period between the firstand second measurements being less than about 30 minutes; and

a processor, adapted to receive the first and second blood pressuresignals, to determine a discrepancy therebetween, and to automaticallyactuate the blood pressure sensor to take a third blood pressuremeasurement if the discrepancy is greater than a determined threshold.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for measuring blood pressure of a user,including:

a blood pressure sensor, adapted to make n measurements of systolicblood pressure (S) and diastolic blood pressure (D) of the user, therebydefining a measurement set M having n elements {(S₁, D₁), (S₂, D₂), . .. , (S_(n), D_(n))}; and

a processor, adapted to process measurement set M, so as to determine astatistical relation among the elements of measurement set M, andadapted to assess, responsive to the relation, a test measurement ofsystolic and diastolic blood pressure, so as to determine whether toidentify a test element (S_(test), D_(test)), corresponding to the testmeasurement, as an outlier with respect to the elements of measurementset M.

Preferably, the processor is adapted to determine a regression among theelements of measurement set M, such as a linear regression.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for measuring and modifying blood pressureof an ambulatory user outside of a healthcare facility, including:

a blood pressure sensor, adapted to make a plurality of measurements ofthe blood pressure of the ambulatory user during a time period spanningat least about a week, and to generate respective blood pressure signalsresponsive to each of the measurements;

an intervention unit, adapted to administer an intervention to theambulatory user a plurality of times during the time period, so as tomodify the user's blood pressure; and

a processor, adapted to receive the blood pressure signals from thesensor, analyze the signals, and automatically modify parameter of theintervention responsive to analyzing the signals.

Preferably, the processor is adapted to (a) perform a statisticalanalysis on the signals, (b) identify one or more of the measurements asoutliers with respect to the other measurements, and (c) automaticallymodify the parameter of the intervention responsive to measurements notidentified as outliers.

Alternatively or additionally, the processor is adapted to (a) calculatea regression based on a measurement set of systolic and diastolic bloodpressure measurements (S_(i), D_(i)), (b) identify as outliers one ormore of the measurements in the measurement set responsive tocalculating the regression, and (c) automatically modify the parameterof the intervention responsive to measurements not identified asoutliers.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for measuring and modifying a physiologicalvariable of an ambulatory user outside of a healthcare facility,including:

a photoplethysmographic (PPG) sensor, adapted to make a plurality ofmeasurements of the ambulatory, user during a time period spanning atleast about a week, and to generate respective PPG signals responsive toeach of the measurements;

an intervention unit, adapted to administer an intervention to theambulatory user a plurality of times during the time period, so as toimprove a future PPG measurement; and

a processor, adapted to receive the PPG signals from the sensor, analyzethe signals, and automatically modify a parameter of the interventionresponsive to analyzing the signals.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for measuring mechanical deformation,including:

a housing;

a base electrode; and

a deformable electrode, mechanically coupled to the base electrode andto the housing, the base electrode and the deformable electrode defininga capacitor having capacitance, such that the capacitance is variedresponsive to deformation of the deformable electrode.

Preferably, a portion of the base electrode is adapted to be at asubstantially fixed distance from a portion of the deformable electrode.

Alternatively or additionally, the deformable electrode is adapted to becoupled to a user, so as to deform responsive to respiration of user.

Alternatively or additionally, the apparatus includes a member,mechanically coupled to the deformable electrode, such that movement ofthe member deforms the deformable electrode and varies the capacitance.

Alternatively or additionally, the apparatus includes a belt, adapted tobe placed around a torso of a user and to cause movement of the memberresponsive to a change in circumference of the torso.

Alternatively or additionally, the member is adapted to be in physicalcontact with the deformable electrode.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for facilitating improving health of auser, including:

a first sensor, adapted to measure a first physiological variable, whichis indicative of an action of the user;

a second sensor, adapted to measure a second physiological variable,which is not entirely under the direct voluntary control of the user;and

circuitry, adapted to receive respective first and second sensor signalsfrom the first and second sensors, and, responsive thereto, to generatean output signal which causes the user to modify, substantiallyunintentionally, a parameter of the action.

Preferably, the first sensor includes a respiration sensor, a bloodpressure sensor, and/or a photoplethysmographic sensor.

Alternatively or additionally, the circuitry is adapted to generate amusical signal which causes the user to modify, substantiallyunintentionally, the parameter of the action.

Alternatively or additionally, the circuitry is adapted to generate theoutput signal while the user sleeps.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for generating music, including:

a sensor, adapted to receive a rhythm signal corresponding to a rhythmof a cyclic physiological activity of a user, the physiological activityhaving first and second activity phases thereof;

a processor, adapted to analyze the rhythm signal to determine afrequency thereof and to determine a new frequency responsive to adesired change of the frequency of the rhythm signal; and

circuitry, adapted to:

-   -   generate at the new frequency a music signal for presentation to        the user, the music signal having first and second music phases        thereof respectively corresponding to the first and second        activity phases, a duration of each of the music phases        expressible as being approximately equal to an integer multiple        of a base duration, the integer multiple being less than or        equal to four,    -   so as to direct the user to modify durations of the first and        second activity phases responsive to the respective durations of        the first and second music phases.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for generating music, including:

a sensor, adapted to receive a rhythm signal corresponding to a rhythmof a cyclic physiological activity of a user, the physiological activityhaving first and second activity phases thereof;

a processor, adapted to analyze the rhythm signal to determine afrequency thereof and to determine a new frequency responsive to adesired change of the frequency of the rhythm signal; and

circuitry, adapted to:

-   -   generate at the new frequency a music signal for presentation to        the user, the music signal having first and second music phases        thereof respectively corresponding to the first and second        activity phases, a duration of one of the music phases being        approximately equal to an integer multiple of a duration of the        other one of the music phases, so as to    -   direct the user to modify durations of the first and second        activity phases responsive to the respective durations of the        first and second music phases.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for generating music, including:

a sensor, adapted to receive a rhythmic physiological patterncorresponding to a rhythm of a physiological activity of a user;

a processor, adapted to analyze the rhythmic physiological pattern todetermine an actual activity pattern thereof and to determine a newactivity pattern responsive to a desired change of the actual activitypattern; and

circuitry, adapted to:

-   -   generate a music signal for presentation to the user, the music        signal having two or more sets of notes, at least one of the        sets of notes having a rhythmic characteristic corresponding to        the new activity pattern, so as to    -   direct the user to modify the rhythm of the physiological        activity responsive to the music signal.

There is also provided, in accordance with a preferred embodiment of thepresent invention, apparatus for generating music, including:

a sensor, adapted to receive a rhythm signal corresponding to a rhythmof a cyclic physiological activity of a user;

a processor, adapted to analyze the rhythm signal to determine a patternthereof and to determine a new pattern responsive to a desired change ofthe pattern of the rhythm signal; and

circuitry, adapted to:

-   -   generate, responsive to the new pattern, a music signal for        presentation to the user; and    -   determine, responsive to a characteristic of the new pattern, a        set of music layers to include in the music signal, the layers        having notes, such that the notes of one of the layers are        played at a generally faster rate than the notes of another one        of the layers, so as to    -   direct the user to modify the rhythm of the physiological        activity responsive to the music signal.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for facilitating improving health of a user,including:

receiving a first physiological variable, which is indicative of avoluntary action of the user;

receiving a second physiological variable, which is not entirely underthe direct voluntary control of the user;

generating an output signal, responsive to the first and secondvariables; and

directing the user to modify a parameter of the voluntary actionresponsive to the output signal.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for facilitating improving health of a user,including stimulating a portion of a body of the user at a stimulationrate between about 0.05 Hz and 0.15 Hz.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for facilitating improving health of a user,including:

measuring a physiological variable of the user; and

determining, responsive to measuring, a frequency of variation of acardiovascular variable of the user that lies between about 0.05 Hz and0.15 Hz; and

stimulating the user at the determined frequency.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for facilitating improving health of a user,including:

measuring a physiological variable of the user; and

generating, responsive thereto, for presentation to the user, two ormore acoustic signals which are configured so as to create a spatialsound effect.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for measuring blood pressure of a user,including:

making first and second blood pressure measurements, a time periodbetween the first and second measurements being less than about 30minutes;

determining a discrepancy between the first and second measurements; and

automatically making a third blood pressure measurement if thediscrepancy is greater than a determined threshold.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for measuring blood pressure of a user,including:

making n measurements of systolic blood pressure (S) and diastolic bloodpressure (D) of the user, thereby defining a measurement set M having nelements {(S₁, D₁), (S₂, D₂), . . . , (S_(n), D_(n))}; and

processing measurement set M, so as to determine a statistical relationamong the elements of measurement set M;

assessing, responsive to the relation, a test measurement of systolicand diastolic blood pressure; and

determining, responsive to assessing, whether to identify a test element(S_(test), D_(test)), corresponding to the test measurement, as anoutlier with respect to the elements of measurement set M.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for measuring and modifying blood pressureof an ambulatory user outside of a healthcare facility, including:

making a plurality of measurements of the blood pressure of theambulatory user during a time period spanning at least about a week;

administering an intervention to the ambulatory user a plurality oftimes during the time period, so as to modify the user's blood pressure;and

analyzing the measurements; and

automatically modifying a parameter of the intervention responsive toanalyzing the signals.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for measuring mechanical deformation,including mechanically coupling a base electrode to a deformableelectrode, the base electrode and the deformable electrode defining acapacitor having capacitance, such that the capacitance is variedresponsive to deformation of the deformable electrode.

There is also provided, in accordance with a preferred embodiment of thepresent invention, a method for facilitating improving health of a user,including:

measuring a first physiological variable, which is indicative of anaction of the user;

measuring a second physiological variable, which is not entirely underthe direct voluntary control of the user; and

generating an output signal which causes the user to modify,substantially unintentionally, a parameter of the action.

The present invention will be more fully understood from the followingdetailed description of the preferred embodiments thereof, takentogether with the drawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of an interventive-diagnostic system,according to a preferred embodiment of the present invention;

FIG. 2 is a schematic block diagram of inputs to a local computingdevice of the interventive-diagnostic system of FIG. 1, according to apreferred embodiment of the present invention;

FIG. 3 is a schematic block diagram showing the local computing deviceof the interventive-diagnostic system of FIG. 1, according to apreferred embodiment of the present invention;

FIG. 4 is a flow chart of a comparator of the local computing device,according to a preferred embodiment of the present invention;

FIG. 5 is a schematic diagram illustrating a number of possibleconfigurations of the interventive-diagnostic system of FIG. 1,according to a preferred embodiment of the present invention;

FIG. 6 is a schematic block diagram showing a number of possible modesin which the local computing device is able to operate, according to apreferred embodiment of the present invention;

FIG. 7 is a schematic illustration showing how theinterventive-diagnostic system of FIG. 1 is applied to a congestiveheart failure patient, according to a preferred embodiment of thepresent invention;

FIG. 8 is a schematic flow chart showing steps involved in arehabilitation program for the patient described with reference to FIG.7, according to a preferred embodiment of the present invention;

FIG. 9 is a schematic illustration showing how theinterventive-diagnostic system of FIG. 1 is applied to an asthmaticchild, according to a preferred embodiment of the present invention;

FIG. 10 is a schematic flow chart giving steps involved in a gameprogram to enhance breathing self-control under psychological stressors,for the child described with reference to FIG. 9, according to apreferred embodiment of the present invention;

FIG. 11 is a schematic flow chart giving steps involved in a bloodpressure treatment program, according to a preferred embodiment of thepresent invention;

FIG. 12 is a schematic flow chart giving steps involved in a process ofproviding the interventive-diagnostic system of FIG. 1 to a user,according to a preferred embodiment of the present invention;

FIGS. 13 and 14 are schematic pictorial illustrations of devices forimproving the health of a user, in accordance with respective preferredembodiments of the present invention;

FIGS. 15A and 15B are graphs, schematically illustrating fictitiousblood pressure data taken from the user shown in FIG. 13, in accordancewith respective preferred embodiments of the present invention;

FIG. 16 is a musical composition map, generated in accordance with apreferred embodiment of the present invention; and

FIGS. 17A, 17B, and 17C are schematic illustrations showing differentaspects of a capacitive sensor, in accordance with a preferredembodiment of the present invention.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 is a schematic illustration of an interventive-diagnostic system20, according to a preferred embodiment of the present invention. System20 comprises a local computing device 26, which receives signal datafrom sensors 23, 24 and coupled to a user 22 at a local site 21.Typically, at least some of the signal data represents biorhythmicactivity of user 22. The signal data comprise signals from one or morehealth status sensors 23, one or more biorhythmic-activity sensors 24and/or one or more benefit-related sensors 25. Local device 26, thesensors, and the signal data received by the local device are describedin greater detail hereinbelow. The connection between local device 26and sensors 24 and 25 may be wired or wireless.

Local device 26 performs a first analysis on the received signals togenerate a set of analyzed data, which is transferred to a remotefacility 28, such as a hospital or medical clinic. A program operator 32and a computer 34, controlled by operator 32, are preferably located atthe facility. Remote facility 28 is physically distant from local device26 and user 22. Preferably, remote facility 28 communicates with localdevice 26 via a distributed network 36 such as the Internet.Alternatively or additionally, program operator 32 and/or computer 34communicate with local device 26 and/or user 22 by other means known inthe art, for example by a telephone modem or by voice, using atelephone.

Operator 32 and/or computer 34 preferably further analyze the data setreceived from local device 26, generating a result which is transmittedto local site 21 and preferably saved in a memory 38 of computer 34. Forexample, the result from remote facility 28 may be verbal help to enableuser 22 to modify operation of device 26, or the remote result may bedata communication to the local device. Local device 26 utilizes theresult from the remote facility, and/or the set of analyzed data, and/orthe signals received from sensors 24 and 25, to generate an interventionwhich is provided to user via a stimulation unit 30. The interventiontypically comprises an intelligible sensory input stimulus, such as asound pattern provided through earphones worn by user 22, a dynamicgraphic pattern provided on a screen visible to the user, or a regularlyrepeating audio and/or visual pattern, such as a metronome. The stimuluspreferably changes at least one aspect of the biorhythmic activity ofuser 22.

FIG. 2 is a schematic block diagram of categories of variables which aretypically input as signals or data to local device 26, according to apreferred embodiment of the present invention. A first category, hereintermed biorhythmic-activity variables, comprises signals generated by abiorhythmic activity of user 22, wherein the biorhythmic activity is onewhich may be modified by the user. For example, biorhythmic activityvariables may be signals generated by an appropriate sensor in responseto the breathing of user 22, or in response to eye-blinking, or inresponse to flexure and/or rigidity of one or more voluntary orsemi-voluntary muscles of the user. Biorhythmic-activity signals aremeasured by one or more appropriate biorhythmic-activity sensors, suchas a force transducer for monitoring breathing movements via changes inchest or abdominal circumference, based on a strain-gauge which isattached to an elastic belt, such as that described by Gavish in theabove-cited U.S. Pat. No. 5,423,328. Preferably, the one or morebiorhythmic-activity sensors are self-installed by user 22.

A second category of variables, herein termed benefit-related variables,comprises signals generated by measurements of physiological variablesof user 22, wherein the variables cannot normally be modified by theuser at will. Typically, benefit-related variables include parameters ofthe user that are altered by a pathology or other phenomenon of user 22which is being treated by device 26. For example, benefit-relatedvariables may be those corresponding to blood pressure, bloodoxygenation (e.g., SpO2), pulse-wave velocity, variations in skin bloodvolume (e.g., as measured by photoplethysmography), respirationparameters (e.g., peak air flow), or an electrocardiogram (ECG)measurement of user 22. Benefit-related variables are measured by one ormore appropriate benefit-related sensors, such as a sphygmomanometer, apulse oximeter, or an electrocardiograph, which are preferablyself-installed by user 22. Alternatively, the one or morebenefit-related sensors are installed by someone other than user 22,such as a parent, if user 22 is a child. Additionally, benefit-relatedvariables may be monitored continuously or at specific time points, suchas when measuring blood pressure by a standard sphygmomanometer.

A third category of variables, herein termed health status variables,comprise data which give details of the general state of user 22. Forexample, health status variables typically comprise weight, height, age,resting respiration rate, and resting heart rate of user 22, as well asthe user's ECG and blood pressure, measured during an interventionsession. As appropriate, device 26 evaluates the health status variablesto determine whether they are within safe ranges. For example, for auser having a specified gender, age, and weight, a certain measuredheart rate may be determined to be too high or too low, and thus force apremature termination of the intervention and an alarm signal.

Preferably, some of the health status variables are input to localdevice 26 via a keyboard which may be coupled to or integrated withdevice 26. Alternatively or additionally, health status variables may beinput to device 26 by connecting the device to a computer. Furthermorehealth status variables may be input to device 26 by an appropriatesensor, such as an electronic weigh-scale, when the variable to be inputis weight. Storage and evaluation of changes of the health statusvariables can be used to determine a trend in the user's medicalcondition, as described hereinbelow.

FIG. 3 is a schematic block diagram showing components of local device26, according to a preferred embodiment of the present invention.Generally, local device 26 generates intervention parameters responsiveto input signals, and provides a stimulus via stimulation unit 30 touser 22, responsive to the intervention parameters. Local device 26 ispreferably implemented in discrete components or a combination ofdiscrete and custom or semi-custom components. Alternatively, device 26is implemented by operating a program on an industry-standard computercoupled to a display monitor.

Device 26 comprises a central processing unit (CPU) 52, which is coupledto and controls the operation of the individual components of device 26described hereinbelow. For clarity, lines are not shown between CPU 52and the other components. It will be appreciated that there are manyways within the scope of the present invention to achieve objects of theinvention, and the particular components and methods described withrespect to FIG. 2 are an example of these. A biorhythmic activitydetector 64 receives a biorhythmic-activity signal, herein designatedBAS, from sensor 24, and generates an output responsive to BAS,representing one or more pattern components of the sensed biorhythmicactivity of the user. Pattern components and other relevant concepts forimplementing detector 64 are described in the above-cited U.S. Pat. Nos.5,076,281 and 5,800,337. Preferably, the output of detector 64 includesintervention parameters, herein termed biorhythm activity parameters(BAP), which are of a quantitative nature. A benefit related detector 62receives a benefit-related signal, herein designated BRS, from sensor25, and generates an output responsive to BRS representing one or morepattern components of the sensed benefit-related signals of the user.Preferably, the output of detector 62 includes intervention parameters,herein termed benefit-related parameters (BRP), which are of aquantitative nature.

A health status detector 60 receives health status data, hereindesignated HSD, by methods described above, and generates an outputresponsive to the HSD representing one or more components of the healthstatus of the user. Preferably, the output of detector 60 includescurrent values relating to one or more physiological variables that maybe altered by application of embodiments of the present invention. Thesevalues are herein termed health status parameters (HSP), and aretypically of a quantitative nature. Intervention parameters BAP, BRP,and HSP most preferably comprise specific time-point analyses of theirrespective signals, which are used to identify special pointscharacterizing the signals' structures, such as maxima, minima, andturning points (e.g., as described by Gavish in U.S. Pat. No.5,800,337). A further set of parameters, herein termed cross-correlationparameters (CCP), are derived by correlating BAS, BRS, and HSP signals,so as generate a cross-correlation and a cross-spectral analysis of thesignals. Most preferably, values of BAS, BAP, BRS, BRP, HSS, HSP, andCCP are stored in a data logger/memory 54, which preferably comprisesindustry-standard volatile and non-volatile memory components.

A comparator 50 receives values of BAP, BRP, HSP, and CCP in order tocompare the values against values which have been previously stored indata logger 54. The operation of comparator 50 is described in detailhereinbelow, with reference to FIG. 4. If the values of BAP, BRP, HSP,and CCP are within predefined limits, comparator 50 enables a driver 46,whose function is to operate a biorhythmic activity modifier 44.Preferably, driver 46 operates by providing a set of operational commandinputs to modifier 44 so as to cause a component of the stimulus inputto the user to be related to a component of the existing biorhythmicactivity of user 22 which is sensed by one or more of sensors 23, 24,and/or 25. Comparator 50 is also able to activate an alarm generator 58,in the event that one or more of the health status parameters and/orbenefit-related parameters are outside a predefined range.

A mode storage component 54 stores a plurality of modes under whichdevice 26 is able to operate, which modes are described in greaterdetail below with respect to FIG. 6. A sequencer 56 interacts with modestorage 54 so as to choose a sequence of modes which is to be utilizedby driver 46 in operating biorhythmic activity modifier 44. Both modestorage and sequencer 56 are addressable by remote facility 28, mostpreferably by interfacing with CPU 52 (as described above for device 26,with reference to FIG. 1), so that sequences of operational modes may beupdated. Operational mode sequences may be modified for a number ofreasons, for example, to optimize a particular therapeutic strategy, toabandon a strategy that is not producing desired results, or simply tokeep user 22 interested. A display 66, most preferably anindustry-standard alphanumeric display, displays to user 22 datacorresponding to signals and parameters described hereinabove, as wellas other data such as help signals, according to commands received fromCPU 52.

Biorhythmic activity modifier 44 receives parameters BAP and BRP,respectively from detectors 62 and 64 and/or from driver 46, andprovides user 22 with a stimulus input which is able to change at leastone aspect of the user's biorhythmic activity. For example, the stimulusinput provided to user 22 may be a sound pattern, which varies over timeto teach user 22 to alter a time period associated with inhaling and/orexhaling.

In some applications, program operator 32 and/or computer 34 interactwith components of local device 26, other than as described above, so asto be able to follow and vary the operation of device 26. Programoperator 32 and/or computer 34 are able to read data from, and writedata to, data logger/memory 54, and also to overwrite any of the datastored in data logger/memory 54. Preferably, threshold values determinedat remote facility 28 are supplied to comparator 50, which are used bythe comparator to perform comparisons described hereinbelow, and whichare herein termed criteria via threshold (CRT) values.

FIG. 4 is a flow chart showing operation of comparator 50, according toa preferred embodiment of the present invention. Typically, healthstatus parameters HSP are compared with CRT values which are input to ahealth range decider. If the values are outside the health rangedelineated by the CRT values, alarm generator 58 is triggered, driver 46is disabled, and a signal announcing the out-of-range state is sent todata logger 54. If parameters HSP are within range, they are used,together with previous HSP parameters from data logger 54, in order tocalculate an updated HSP trend. The new trend is checked to see if it iswithin acceptable limits, using HSP trend criteria derived from the CRTvalues. If the HSP trend is in within acceptable limits, driver 46 isenabled. If the HSP trend is not within acceptable limits, driver 46 isdisabled. The trend of a parameter may be evaluated by analyzingrepeated measurements thereof over a prescribed period. Preferably, theanalysis comprises a statistical analysis, such as calculating aregression to determine a slope and to know the statistical significanceof the determined slope. Alternatively or additionally, othercurve-fitting methods known in the art may be used.

Benefit-related parameters BRP are used, together with previous BRPparameters from data logger 54, in order to calculate an updated BRPtrend. The new trend is checked to see if it is within an acceptablerange, using BRP trend criteria derived from the CRT values. If the BRPtrend is within the acceptable range, no further action is taken bydevice 26. Otherwise, a signal announcing the out-of-range state is sentto data logger 54, and a driving strategy selector is informed. Thedriving strategy selector determines which parameters of driver 46 areto be modified, to what degree, and in what manner. In order to make itsdetermination, the selector also receives an analysis of the performanceof user 22. The analysis is performed by comparing the BAP parameterswith the CCP parameters generated by detector 62, and may be responsiveto inputs from remote facility 28.

FIG. 5 is a schematic diagram illustrating a number of possibleconfigurations of system 20, according to a preferred embodiment of thepresent invention. In a first configuration, user 22 is coupled todevice 26 as described hereinabove with reference to FIG. 1. While user22 is operating device 26, the user contacts remote facility 28 andrelays the data displayed by display 66 to program operator 32. Mostpreferably, user 22 contacts operator 32 by telephone, and verballyrelates the data shown on the display. Program operator 32 analyzes therelayed data, and verbally informs user 22 of the results of theanalysis, whereupon, depending on the results, user 22 may be instructedto make adjustments to device 22. It will be appreciated that aconfiguration such as that illustrated is especially useful when device26 is operated by user 22 as a generally self-contained unit, whereinuser 22 requires help and/or instruction in operating the device andmodifying parameters thereof.

In a second configuration, user 22 sets device 26 to communicatedirectly with computer 34 in remote facility 28, during an interventionsession, or following one or more sessions. User 22 contacts programoperator 32, preferably via telephone, to inform the operator thatdevice 26 is connected, whereupon the operator is able to download andinspect data from components of device 26, such as data in data logger54. Alternatively or additionally, program operator 32 is able to altersettings of device 26, for example, by uploading new music or new valuesof CRT parameters to the device, and is also able to communicateverbally with user 22. This configuration is useful when device 26 is tobe checked and/or updated by operator 32 on an intermittent basis. Theconfiguration is also useful for enabling program operator 32 to informuser 22 of his progress, based on data stored in device 26.

In a third configuration, device 26 preferably comprises a localindustry-standard personal computer coupled to a display monitor, asdescribed hereinabove with respect to FIG. 3. One or more of sensors 23,24 and/or 25 are coupled to the local computer. The local computercommunicates with computer 32 at remote facility 28, preferably vianetwork 36, so that, for example, a new audiovisual multimedia output isable to be transmitted from the remote facility to the local computer.In addition, program operator 32 is able to communicate with user 22,for example by telephone as described above, and/or by anindustry-standard network communication program installed on the localcomputer and on computer 32, such as a chat program. This configurationis useful when full two-way continuous communication between remotefacility 28, user 22, and device 26 is required. In this configuration,for example, messages, data reports, and verbal and non-verbalinformation may be exchanged.

FIG. 6 is a schematic block diagram showing a number of possibleoperational modes of local device 26, according to a preferredembodiment of the present invention. Most preferably, mode storagecomponent 54 holds parameters corresponding to the modes describedhereinbelow. In an intervention mode, device 26 generates a stimulus foruser 22, with the intention of modifying a variable of user 22. In adiagnostic mode, device 26 performs one or more measurements of avariable of user 22, without modifying the variable. In adiagnostic-interventive mode, device 26 initiates an intervention andperforms a diagnosis, or repeatedly cycles between diagnosis andintervention in any desired pattern. In a testing mode, device 26executes a programmed sequence of interventions and/or diagnoses, inorder to characterize physiological variables of user 22. Mostpreferably, sequencer 56 stores a plurality of programmed sequences. Ina hold mode, device 26 is placed into a waiting state until activated byan action of user 22 or remote facility 28.

Examples of modes which typically are applicable to users withcongestive heart failure, although the modes may also be applied toother users, are described in Table I hereinbelow. A notation which maybe used to characterize the mode is also given in the table.

TABLE I Mode Notation Description Intervention 1 I1(RR) Slow downbreathing pattern using a musical pattern stimulus. The pattern isimplemented interactively, at a breathing rate (RR breaths per minute)set by a predetermined algorithm. Intervention 2 I2(RR, T) Entrainbreathing at a rate of RR breaths per minute, for a period of T minutes.Diagnosis 1 D1(C) Measure and record parameters based on breathing. WhenC = 1, record signals and parameters in data logger 54. When C = 0 ,record only parameters in the data logger. Diagnosis 2 D2(C) Measure andrecord parameters based on breathing and pulse oximetry. Diagnostic- DI1Perform D1(1) followed by I1, so as Interventive 1 to measure long-termbenefit parameters, and then perform a therapeutic intervention. Testing1 T1 A sequence [D2, I2(15, 2), I2(10, 2), I2(16, 2), D2] measures acuteresponse to intervention, to characterize parameters of thecardiovascular control system.

Examples of modes which typically are applicable to users who areasthmatic children, although the modes may be applied to other users,are described in Table II hereinbelow.

TABLE II Mode Notation Description Intervention 3 I3 Present scenesincluding a psychological stressor, e.g., in the context of a videogame. Intervention 4 I4 Present “neutral” scenes, without apsychological stressor. Diagnosis 3 D3 Measure and recordbreathing-related parameters. Testing 2 T2(1) Perform a sequence [D3 ,I1(1), D3] to measure acute response to the intervention, and tocharacterize physiological variables which are sensitive to thestressor.

FIG. 7 is a schematic illustration showing system 20 applied to acongestive heart failure patient, according to a preferred embodiment ofthe present invention. Sensor 24 preferably comprises a forcetransducer/respiration sensor 70 (such as the force transducer describedhereinabove with reference to FIG. 2), coupled to a belt placed aroundthe chest of user 22, who is a congestive heart failure patient. Sensor25 comprises a pulse oximeter 72, which is placed on a finger of user22. Such sensors, and their method of application and use, are wellknown in the art. Stimulation unit 30 preferably comprises a set ofearphones 72 worn by user 22, which provide a music-like patternaccording to outputs from biorhythmic activity modifier 44.Alternatively or additionally, unit 30 comprises an external speaker,for example, the loudspeaker of a personal computer. Device 26 usesinput signals from sensor 70 to generate biorhythmic activity parameterscorresponding to a respiration rate, an inspiration time, an expirationtime, and a desired graded performance of user 22. Device 26 also makesmeasurements of benefit-related parameters derived from patternclassification statistics, such as a percentage of time spent in apathological breathing state, oxygen saturation levels and theirfluctuations, and heart rate.

FIG. 8 is a schematic flow chart showing steps involved in arehabilitation program for the patient described with reference to FIG.7, according to a preferred embodiment of the present invention.Preferably, remote facility 28 and user 22 operate in configuration 1,as described hereinabove. In an introduction step, operator 32introduces user 22 to device 26 and the program described hereinbelow.Operator 32 also determines appropriate patient characteristics, fromdata logger 54, and then transmits initial setup parameters to device26. Finally, operator 32 instructs user 22 to operate device 26 between6 AM and 10 AM each day, during the course of the program.

In a “set baseline” step, user 22 fills in a questionnaire, to providedetails of currently-prescribed medications, lifestyle, etc. to remotefacility 28. Subsequently, user 22 uses device 26 during ten days ofmeasurements, in which signals and parameters are recorded,corresponding to D2(1) of Table I. After completion of the ten days ofmeasurements, user 22 performs an acute-response test corresponding toT1 of Table I. Device 26 then moves to hold mode until activated byoperator 32.

In an initial analysis step, data stored in data logger are transmittedto remote facility 28, where operator 32 reads and analyzes the data.Operator 32 then transfers appropriate parameters CRT to device 26, toenable regular operation of the device.

In a first operation step, user 22 operates device 26 indiagnostic-interventive mode DI1 for one week, after which device 26moves to hold mode. User 22 transmits data stored in data logger 54 toremote facility 28. Most preferably, the data is transmitted accordingto configuration 2, described hereinabove. Alternatively, user 22 maycontact operator 32 and transmit the data in one of the alternativeconfigurations described above. After the data have been transmitted tooperator 32, device 26 returns from hold to its normal working mode.

In a second operation step, user 22 and operator 32 repeat the initialanalysis step and the first operation step for four weeks. At thecompletion of this step, user 22 performs acute-response test T1described in Table I. User 22 also fills in a second questionnaire.

In a third operation step, user 22 and operator 32 repeat the initialanalysis step and the first operation step for between two and fourmonths, while operator 32 checks the data and modifies operation ofdevice 26 as described above.

In a completion step, user 22 completes both questionnaires, and isinvited to remote facility 32 to discuss the results of the program.

FIG. 9 is a schematic illustration showing how aspects of system 20 areapplied in the form of a computer game for user 22, in this case anasthmatic child, according to a preferred embodiment of the presentinvention. Preferably, the application is for the purpose of enhancingself-control of user 22's breathing when exposed to psychologicalstressors. Optionally, wheezing is monitored as a benefit-relatedvariable. Alternatively or additionally, respiratory efforts areincreased by user 22 by breathing through a resistive load, in order tostrengthen and orchestrate the activity of respiratory muscles.

Most preferably, device 26 is implemented in a computer comprising anaudiovisual monitor 76, as described hereinabove. Respiration sensor 70,described above with reference to FIG. 7, is coupled to a belt placedaround the chest of user 22. Sensor 70 is preferably coupled directly tocomputer 74, for the purpose of monitoring wheezing as a benefit-relatedvariable. Typically, wheezing is detected by mounting a small microphone(not shown) near user 22's throat. Computer 74 and user 22 arepreferably, but not necessarily, in communication with remote facility28, as described above with reference to configuration 3, so thatoperator 32 is able to present a dynamic audio-visual pattern, e.g., agame, as a sensory stimulus to user 22. Computer 74 uses input signalsfrom sensor 70 to generate biorhythmic activity parameters correspondingto a respiration rate, an inspiration time, an expiration time, and agraded performance of user 22. Most preferably, the graded performancequantitatively characterizes the breathing of user 22, and comprises,for example, a percentage of time during a session spent executing aprescribed breathing procedure, or other prescribed intervention.

Device 26 also makes measurements of benefit-related parameters derivedfrom pattern classification statistics, respiration rate, inspirationtime, and expiration time. Such benefit-related parameters include, forexample, a percentage of time spent in a pathological breathing pattern.Device 26 also makes measurements of health status parameters derivedfrom the respiration rate of user 22.

FIG. 10 is a schematic flow chart showing steps of a game program toenhance breathing self-control during exposure to psychologicalstressors, for the child described with reference to FIG. 9, accordingto a preferred embodiment of the present invention. In an introductionstep, operator 32 communicates with user 22 and explains rules to befollowed during the course of the game program, for example, how tomount sensor 70 correctly. Preferably, the explanations compriseaudiovisual explanations and/or questions and answers via an electroniccommunications program, such as a chat program. The introduction stepconcludes by user 22 demonstrating to operator 32 that the user is ableto correctly mount sensor 70 and operate device 26.

In a “learn control” step, user 22 is given a short course in how tocontrol her/his breathing, typically by slowing down breathing usingintervention mode I1, as described above in Table I. Preferably, thestimulus presented to user 22 is in the form of a moving picture onmonitor 76, such as an object whose activity responds to the user, and,to encourage proper breathing, can only enter a “high-score” region ofthe screen when the user's breathing profile closely matches a desiredprofile. Alternatively or additionally, the size or content of an oxygenbottle carried by an on-screen spaceman, varies in apparent volume orother characteristics responsive to the breathing profile. As describedhereinabove, the actual variation of the stimulus is controlled by theoutput of biorhythmic modifier 44. Preferably, the course includescompiling for user 22 a score representative of how well the course hasbeen followed.

In an evaluation step, diagnosis mode D3, described above in Table II,is applied to user 22, and the results are evaluated by operator 32. Atthe conclusion of the evaluation, operator 32 transmits parameters CRTto computer 74 so as to alter parameters of the game responsive to theevaluation of the operator.

In an altered game step, user 22 plays the game under the alteredconditions. Most preferably, the altered conditions include one or more“adventure” sessions, and one or more “break” sessions. An adventuresession typically comprises an intervention mode wherein a psychologicalstressor is applied, for example I(3) described in Table II. Thestressor may be, for some applications, the tension induced in the userby the game's difficulty. A break session comprises an intervention modewherein no psychological stressor is applied, for example interventionmode I4 described in Table II. During the course of the altered gamestep, sensitivity to the stressor is measured, e.g., by testing modeT2(1), and the results of the test are used to alter the structure ofthe game. For example, the percentage of adventure sessions may beincreased and the percentage of break sessions may be correspondinglydecreased. User 22 most preferably receives scores giving an evaluationof the user's performance during the course of the altered game step.

The game continues by repeating the evaluation step and the altered gamestep, the repetition being made conditional on user 22 achieving aspecific score in the altered game step. Most preferably, eachrepetition increases the level of difficulty of the game, e.g., byincreasing the percentage of time spent in adventure sessions.

In some preferred embodiments of the present invention, a plurality ofgames, which are similar to the game described with reference to FIG.10, are operated by a corresponding plurality of users. Most preferably,the users are in communication with each other via network 36, so thatrespective scores of the users are visible to some or all of the users.Most preferably, operator 32 is also able to see the plurality of scoresof the users. Friendly competition or team-work between the users may beencouraged, for the benefit of all.

In some preferred embodiments of the present invention, the game asdescribed with reference to FIG. 10 is operated by user 22 without theintervention of operator 32, optionally under the supervision of anadult. In these embodiments, the functions of operator 32 mayalternatively be performed by device 26, whereby a mode and a sequenceof program steps are stored respectively in mode storage component 54and sequencer 56.

It will be understood that whereas preferred embodiments of the presentinvention have been described generally with respect to a user having apathology, it is within the scope of the present invention for the userto be generally healthy, and to choose to use aspects of the presentinvention in order to obtain psychological stress-relief and/orrelaxation, or for purposes of muscle re-education, athletic training,or entertainment.

FIG. 11 is a schematic flow chart showing steps involved in a bloodpressure treatment program, according to a preferred embodiment of thepresent invention. An objective of the program is to reduce the bloodpressure of user 22 within a period of about 6 weeks. Most preferably,system 20 is set up as described above with reference to FIG. 9, so thatuser is connected to device 26 and respiration sensor 70. Alternatively,device 26 is implemented as a stand-alone device. Further alternatively,other sensors may additionally be used, such as a photoplethysmography(PPG) sensor, an ECG sensor, or a blood pressure monitor. Depending onthe sensors used, benefit-related parameters comprising rate andstability of breathing, state of small blood vessels, heart ratevariability, values of pulse wave velocity, and blood pressure areutilized in performing the program. Health status variables used in theprogram typically comprise blood pressure, heart rate and heart ratevariability, and breathing pattern.

In an introduction step, user 22 receives device 26 and appropriatesensors. Operator 32, who is most preferably a physician, introducesuser 22 to the program, and provides user 22 with instructions as to howto operate device 26 and the sensors. This step may take place at remotefacility 28, or partly at the remote facility and partly at site 21.

In an initiation step, user 22 performs self-training, after which,measurements are made to determine the user's baseline characteristics.At the end of the baseline characterization, user 22 performs varioustests. Operator 32 accesses device 26 to download the data generated bythe program to date, and analyzes the data. The results of the analysisare then used by operator 32 to set up device 26, for example, includingappropriate parameters and a choice of music to be stored in the modestorage component of device 26.

In a main program step, user 22 treats himself for an extended period oftime, for example 4 weeks. During this time operator 32 monitors datagenerated by the treatment. In case of difficulty, operator 32 and user22 are able to communicate with each other, for example, to provide helpto user 22 in performing the treatment. This step is repeated as needed,and during the course of the step, operator 32 modifies the setup ofdevice 26 according to the progress of user 22.

FIG. 12 is a schematic flow chart showing steps involved in a process ofproviding system 20 to user 22, according to a preferred embodiment ofthe present invention. Device 26 and one or more of sensors 24 and 25are provided to user 22 from remote facility 28, or from anotherfacility remote from local site 21, so that user 22 is able to transportthe device and sensors to the local site, such as the user's home.Alternatively, device 26 is provided to user 22 as a program which canbe installed in a computer operated by the user at local site 21. Mostpreferably, when device 26 and/or the sensors are provided to user 22,the user enters into an agreement with remote facility 28 or with theother remote facility, so as to be able to fully implementinterventive-diagnostic system 20, as described hereinabove. Preferably,the agreement provides for user 22 to receive services from remotefacility 28, which services comprise facility 28 operating system 20 foran evaluation period without user 22 paying for the services. In theevent that user 22 wishes to continue the services after the evaluationperiod, the user, an insurance company, or another entity pays for theservices, for example on a monthly basis. In the event that user 22 doesnot wish to continue to receive the services, the program is terminated.

It will be understood that it is within the scope of the presentinvention for an intervention, as described hereinabove, to include useof physical apparatus not specifically mentioned. This apparatus maycomprise, for example, substantially any anaerobic or aerobicrecreational or therapeutic exercise equipment known in the art.Alternatively or additionally, the apparatus may comprise an airwayresistance-generation device, such as a Positive End Expiratory Pressure(PEEP) valve, an inspiratory or expiratory breathing retrainer, or otherrespiration-manipulation unit. Alternatively, the intervention may bepartially or completely free of apparatus, and involve, for example, 15minutes of walking, pursed-lips breathing, a Valsalva maneuver oraerobic exercise in time-relation with breathing movements (e.g., asapplied in Qi-gong), or intentionally-generated breathing patterns, asdone in Yoga and zan-zen. In some of these applications, principles ofthe present invention may be utilized in combination with a medicaldevice already in use by the user, such as a ventilator. The principlesmay be applied, for example, to wean the user from the ventilator.

FIG. 13 is a schematic pictorial illustration of a device 120 forimproving the health of a user 100, in accordance with a preferredembodiment of the present invention. For many applications, device 120functions according to protocols substantially similar to those whichgovern the function of local computing device 26, described hereinabove.

It will be appreciated that although many functions of device 120 aredescribed with respect to the device operating in a stand-alone mode,particular advantages can nevertheless be obtained by transferring dataand instructions, through a data port 140 of the device, to and from aremote server, as described hereinabove. Typically, device 120 accessesthrough the Internet a Web page maintained by the server, and displayson a screen 128 recommendations which are generated by the server or bya case manager who intermittently reviews data sent by device 120 to theserver. The server or the case manager preferably analyzes the data todetermine the efficacy of the therapy provided by device 120, to changeoperating settings of the device, and/or to identify the onset of adeveloping abnormal or dangerous condition of user 100. The datapreferably comprise diagnostic variables measured by device 120, as wellas data keyed-in by the user. Further preferably, the analysis includesa review of these data, of other treatments administered to the user(e.g., pharmaceutical treatments), as well as of the user's compliancewith these treatments. Still further preferably, a report isperiodically generated by the server, and is sent to the user'sphysician and/or to the user. Alternatively or additionally, the userand/or the device prepares the report prior to the user visiting his/herphysician.

Device 120 preferably comprises a speaker 130 and/or a headset 135,through which music is played or instructions are given, such that incombination with voluntary action by the user, one or more physiologicalvariables of user 100 may be beneficially modified. Preferably, themusic is generated by a processor 122 of the device, in a mannersubstantially similar to that described hereinabove and in theabove-cited patents to the present inventor. Alternatively oradditionally, the music is generated in accordance with the methodsdescribed hereinbelow with reference to FIG. 16. Further alternativelyor additionally, processor 122 drives screen 128 to display graphicalpatterns, images, or instructions which direct the user to modify anaspect of his respiratory pattern or of another controllablephysiological variable. In this case, the material presented on screen128 is preferably configured to vary in its rhythm, color, or perceivedmotion in a manner analogous to that produced by the music algorithmsdescribed herein and in the patents to the present inventor which areincorporated herein by reference. A keypad 126 is optionally provided toallow user 100 to enter various forms of data, e.g., responses toquestions displayed on screen 128.

One or more sensors 170 are preferably coupled to the user's body, andmeasure physiological variables over which user 100 generally exercisesno direct control, i.e., physiological variables typically governed atleast in part by the autonomic nervous system. Typically, sensors 170comprise at least one of the following: a blood pressure cuff 160, arespiration unit 172, photoplethysmography or blood oximetry sensors 156and 158, and electrocardiographic electrodes 154. For some applications,sensors (not shown) which measure other physiological variablescontrolled by the autonomic nervous system are alternatively oradditionally coupled to convey signals to processor 122.

In addition to sensors 170, at least one other sensor 152 is preferablycoupled to convey to processor 122 signals responsive to a physiologicalvariable which is generally under the user's direct control, forexample, respiration rate. In a preferred embodiment, sensor 152 isattached to a belt 150 placed around the user's chest, and is adapted tomeasure the timing and the depth of the inspiratory and expiratoryphases of the user's respiration. Suitable sensors and other apparatusand techniques for use with this embodiment of the present invention aredescribed in the present patent application (particularly with referenceto FIGS. 17A, 17B, and 17C hereinbelow), in the above-cited patents toGavish, in U.S. patent application Ser. Nos. 09/101,540 and 09/191,517,and in PCT Patent Publication WO 97/26822, all of which share commoninventorship with the present patent application and are incorporatedherein by reference.

In a preferred application, processor 122 guides user 100 to changehis/her breathing pattern in a way that typically increases tissueoxygenation. This application of the present invention is particularlyuseful in the treatment of congestive heart failure (CHF), which oftencauses afflicted patients to demonstrate an abnormal breathing patterncalled Cheyne-Stokes respiration, in which periods of hyperventilationare followed by periods of apnea. This breathing pattern leads to a dropin average tissue oxygenation, because excessively-slow breathing doesnot supply sufficient levels of oxygen to the body, and hyperventilationplaces a severe load on the patient's already weak heart and does notoptimally oxygenate the body. Preferably, musical patterns as describedherein include musical or vocal guidance to the user to inhale and toexhale according to a schedule which gradually brings his respirationinto a desired, healthy pattern, so as to increase tissue oxygenation.In accordance with a preferred embodiment of the present invention,protocols described in the above-cited articles by Mortara and Bernardiare utilized in applying the techniques described herein, so as toobtain desired increases in tissue oxygenation. The musical or vocalguidance to inhale may include, for example, a flute playing a sequenceof notes which generally rises in pitch and/or volume, while thedirection to exhale may include cello notes which fall in pitch and/orvolume. Alternatively, the user is instructed at the beginning of thesession to inhale whenever he hears a flute or a tone having a specifiedhigh pitch, and to exhale whenever s/he hears the cello or a tone havinga specified low pitch. Preferred protocols for generating the music aredescribed hereinbelow with reference to FIG. 16.

In some applications, sensor 156 conveys to processor 122 signals whichare indicative of skin blood volume and/or blood oxygen levels. Inresponse, the processor adjusts rhythmic parameters of the music, so asto direct the user to modify the duration of the inspiratory phaseand/or the expiratory phase, and to thereby drive the signals fromsensor 156 towards desired values. For example, the inventor has foundthat programming device 120 to gradually increase the proportion ofrespiration spent in the expiratory phase, while simultaneouslygradually reducing the respiration rate to about six breaths per minute,yields the desired results of significant increases in blood oxygenationand significant decreases in blood pressure in some patients.

In a preferred embodiment, processor 122 stores in a memory 124 ofdevice 120 some or all of the physiological data recorded during asession, as well as parameters of the music or other interventions whichwere applied during that session. The processor preferably analyzesthese data and parameters to determine optimum intervention settings forthe user. It is noted that as the health of the user changes (e.g., overthe course of days or weeks), these settings may also change, so theoptimization process is preferably performed after every session, or inreal time during a session.

In a manner analogous to that described hereinabove with respect toblood oxygenation, other autonomic nervous system functions can bemonitored and varied using device 120, in accordance with a preferredembodiment of the present invention. For example, decreased heart ratevariability is known in the art to be associated with cardiovascularimpairment. (See, for example, the above-cited article by La Rovere etal.) To treat this phenomenon, in one application electrocardiographicelectrodes 154, blood pressure cuff 160, sensors 156 and/or sensors 158send signals to processor 122 indicative of the heart rate of user 100,and processor 122 modifies aspects of the music or other intervention soas to increase heart rate variability. It has been shown that slowbreathing increases heart rate variability. (See, for example, theabove-cited article by Pitzalis et al.)

Alternatively or additionally, device 120 is operated so as to increasethe mechanical compliance of the user's blood vessels. This compliancereflects the ability of blood vessels to expand in response to passagetherethrough of blood ejected from the heart. Sufficient levels ofarterial compliance are known to be important in buffering the pulsatilepattern of the blood pushed at high pressure from the heart, therebysmoothing the flow of blood into the microvasculature. Reduced arterialcompliance, by contrast, is associated with improper function ofbaroreceptors which are used by the body in the feedback systems whichcontrol blood pressure. Arterial compliance is known to decrease withincreasing age, as well as in many cardiovascular diseases, such ashypertension, congestive heart failure, and atherosclerosis. Moreover,arterial compliance decreases in response to an acute increase in bloodpressure, and in response to increased sympathetic nervous activity,e.g., when a person is experiencing mental stress.

Preferably, device 120 increases arterial compliance in a mannergenerally analogous to that described hereinabove with respect toincreasing blood oxygenation. Thus, processor 122 may modify parametersof the music or other intervention presented to the user in order todetermine suitable operating parameters which cause signals from one ormore of sensors 170 to indicate that arterial compliance is increasing.The inventor has found that many cardiovascular indicators are optimizedby causing the respiration rate or another voluntary or involuntaryphysiological parameter of the user to cycle at approximately 6repetitions per minute.

Changes in arterial compliance are preferably measured by monitoringchanges in the pulse wave velocity corresponding to each beat of theuser's heart. Decreases in pulse wave velocity are generally desired, asthey are derived from increases in arterial compliance. Changes in thepulse wave velocity are typically measured by calculating the time delaybetween events corresponding to the same heart beat that are measured atdifferent distances from the heart. For example, processor 122 maymeasure changes in the time difference between the QRS complex of theelectrocardiographic signal measured by electrodes 154 and the onset ofa corresponding change in the photoplethysmography signal measured bysensor 156. Alternatively or additionally, the processor determines thedifference in time between the detection of a cardiac contraction bysensor 158 on the user's ear, and the detection of the same contractionby sensor 156, coupled to one of the user's fingers.

Preferably, processor 122 sets the musical breathing directions or otherapplied interventions so as to maximally decrease the pulse wavevelocity measurements, while substantially continuously monitoring theuser's ability to comfortably adhere to the breathing or other regimen.For example, even if it were determined that an additional marginaldecrease in pulse wave velocity could be attained by reducing therespiration rate from six to five breaths per minute, such a reductionwould typically not be done if it were also determined that the userwould take excessively large breaths at the slower rate and/or overloadthe heart and respiratory muscles.

For some applications of the present invention, it is desirable to applyan intervention to user 100 at a frequency between about 0.05 Hz and0.15 Hz, which corresponds to the vasomotor frequency associated with“Mayer waves”—periodic fluctuations in lumen of the smaller bloodvessels. For example, the user may be directed to breathe at thevasomotor frequency, or blood pressure cuff 160 may be adapted tocyclically apply pressure to the user's arm at this frequency.Alternatively or additionally, other stimulating apparatus applies toother areas of the user's body cyclic doses of a mechanical input, suchas positive or negative air or fluid pressure. Further alternatively oradditionally, electrodes 154 or other electrodes, magnets, heating orcooling units, or electromagnetic radiation emitting units placed on,in, or near the user's body, apply or remove at the vasomotor frequencycorresponding forms of energy to or from the designated areas of theuser's body.

In a given individual, the vasomotor frequency varies over long periodsof time, and, the inventor believes, even during short time periods suchas a typical 15 minute session when user 100 is interacting with device120. Preferably, sensor 156, sensor 158, and/or other sensorssubstantially continuously convey signals to processor 122 which areindicative of a current value of the vasomotor frequency of user 100. Itis hypothesized that by closely matching the frequency of application ofan intervention to the current value of the vasomotor frequency, device120 is able to achieve a form of cardiovascular resonance, which inducessignificant improvements in known indicators of cardiovascular health.(See, for example, the above-cited article by Cook et al.) Theintervention may include any of the interventions described herein, suchas induced changes in respiration rate, cyclically applied mechanicalpressure, heat, cooling, or application of electrical fields, magneticfields, or various forms of electromagnetic radiation. In a preferredembodiment, one or more of these interventions is applied cyclically atthe vasomotor frequency to injured tissue, in order to enhance thehealing of the tissue.

For some applications, respiration unit 172 monitors and/or modifies theairway resistance or the mechanical load of the respiratory system ofuser 100. If appropriate, based on the user's medical condition,respiration unit 172 may cause the user to inhale or exhale against amechanical load, so as to exercise his/her respiratory muscles and/or todilate or otherwise affect some of the respiratory passages.Alternatively or additionally, processor 122 directs the user (e.g., viathe music) to modify aspects of his/her inspiration and expiration, soas to modulate a measured value of airway resistance or mechanical load,and to thereby improve mechanical or other characteristics of his/herrespiratory system. Further alternatively or additionally, in responseto blood oxygenation levels monitored by sensor 156, processor 122actuates electromechanical apparatus (not shown) to change themechanical load engendered by respiration unit 172 on user 100. In thismanner, it is possible to maximize the user's endurance, while avoidingoverloading the user's heart. Suitable forms of breathing maneuvers andother exercises are known in the art, and include those performed inhospitals before and after abdominal and thoracic surgery, as well asthose performed by patients with chronic obstructive pulmonary disease.

In cases where a patient has chronic obstructive pulmonary disease(COPD), it is known in the art to instruct the patient to increase hisrespiratory endurance by breathing breaths per minute through aninspiratory load, while spending 60% of each respiratory cycle inhaling,and 40% of the cycle exhaling. Because of the high levels of mentalconcentration and physical effort that such an exercise requires, andbecause of the relatively boring nature of the task, most patients havedifficulty following such a regimen, and even dedicated patients tend tostop performing the exercise except under the direct supervision of ahealthcare worker.

In preferred embodiments of the present invention, by contrast, themental effort is substantially eliminated, because user 100 need onlylisten to the music and breathe in accordance with its rhythm andpattern. In addition, by being responsive in real-time to the user'scurrent breathing pattern, this embodiment provides significantly morefunctionality than would, for example, an “inhalation indicator light,”which simply has a 60% duty cycle and turns on 15 times per minute.Processor 122, by contrast, typically gradually changes the user'sbreathing pattern from its initial measured state (e.g, 8 breaths perminute, 30% inhale and 70% exhale) to the desired final state.Preferably, this change is caused by guiding the user's respirationthrough a two-dimensional parameter space defined by {[Breathing Rate],[Inspiration:Expiration Ratio]}. Typically, the processor guides theuser's respiration from a point in the space representing the initialstate, along the shortest path through the space, to a point in thespace representing the desired final state. It is noted that, unlike theabove-mentioned blinking light or a pre-recorded cassette, the processorpreferably tracks the user's ability to breathe at each of the pointsalong this path, and does not direct him/her to push harder towards alater goal if s/he has not successfully attained the current respirationrequirement.

It is known that the respiratory system of some patients is slow torecover following surgery, and that other patients take days or weeks tosuccessfully wean themselves from a mechanical ventilator. Therefore,some applications of the present invention are directed towards usingthe apparatus and methods described herein, mutatis mutandis, togradually retrain ventilator-dependent or post-surgery patients inproper breathing techniques. Many mechanical ventilators for use withalert patients are triggered to support the patients' breathing efforts,rather than to dictate the timing and depth of every breath. Becausesome embodiments of the present invention utilize the user's voluntarycontrol over his/her own breathing, it is preferable to use suchtriggered ventilators when employing device 120 to weanventilator-dependent patients.

FIG. 14 is a schematic pictorial illustration of a device 220 forimproving the health of a user 200, in accordance with a preferredembodiment of the present invention. User 200 is shown in FIG. 14 as arunner, but may alternatively be a weight-lifter, swimmer, dancer, orsubstantially anyone who performs a repetitive and/or rhythmic activityand is able to modify a timing characteristic of the activity responsiveto directions from device 220. The device is preferably configured in afashion which is generally similar to device 100, described hereinabovewith reference to FIG. 13. Although for some applications, device 200 iscoupled to a plurality of sensors applied to different portions of theuser's body (as shown in FIG. 13), device 200 is preferably adapted tobe coupled to a small number of sensing and/or actuating elements, suchas, for example, a single element 232.

Typically, element 232 performs sensing functions, e.g., sensing ofmotion of one of the user's legs and photoplethysmographic sensing.Alternatively or additionally, element 232 senses other physiologicalvariables of user 200, and is placed at an appropriate location in or onthe user's body so as to optimally perform this function. In a preferredembodiment, element 232 additionally comprises an actuating unit, whichis driven by device 220 to apply, for example, a fast mechanicalvibration to one of the user's legs to tell him that that leg should beat a particular phase of the running cycle.

In a preferred application of this embodiment, device 220 continuouslymonitors the heart rate of user 200, and triggers element 232 to applythe mechanical vibration or other stimulus to the user, so as to directthe user to change the pace of his running in accordance therewith, suchthat the heart rate is maintained within predetermined limits.Optionally, these limits can be set to vary during the course of a 20minute exercise session, e.g., 80-100 beats/minute during the first fiveminutes, 100-140 beats/minute during the second five minute period,140-180 beats/minute during the third five minute period, and 80-100beats/minute during the final five minute period.

In addition to or instead of the mechanical vibration, a headset 230 maybe driven by device 220 to play music in which a readily-perceivedaspect of the rhythm of the music, such as the downbeat of each measure,is timed to occur at a time when it is desired that the user's left footstrikes the ground. Optionally, the headset includesphotoplethysmographic or other sensing capabilities. People who haveexercised while listening to powerfully-rhythmic music know the strongentraining effect of listening to their favorite music while running orperforming other types of exercise. Consciously or unconsciously, thebody exerts itself to keep up with the rhythm of the music. Yet,inevitably, exercise performed to the rhythm of pre-recorded music issub-optimal, because either (a) the music is somewhat slower than thatwhich is appropriate for the current stage in the person's exercise, andthus does not cause him to work hard enough, or (b) the music issomewhat faster than is appropriate, or does not slow down when theperson starts to run up a steep hill, so the heart rate increases beyondthe desired range. Thus, pre-recorded music, no matter how energetic andinspiring, does not give a listener an optimal work-out. By contrast,music algorithms running in device 220 are preferably continuously ableto increase or decrease parameters of the music (e.g., the music'svolume or tempo) as appropriate, responsive to changes in the user'sheart rate or to changes in other physiological variables. For example,the tempo may be decreased if measured electrocardiographic and/orbreathing patterns indicate that the user's body is working too hard,e.g., if it has started metabolizing energy sources in an inefficientmanner.

In a preferred embodiment, device 220 utilizes stereo spatial effects toenhance the entrainment of the user's running to the music. For example,the music may include a drum beat in the user's left ear each time hisleft foot is supposed to push off the ground, and a drum beat in theuser's right ear each time his right foot is supposed to push off theground. Alternatively, three-dimensional spatial effects are employed bydevice 200, e.g., to present an instrumental sound in the user's left(/right) ear, which sounds like it is moving from the user's back-left(/right) to his front-left (/right), in correspondence to desired motionof the user's left (/right) leg. Similarly, for some applications,device 120 (FIG. 13) generates sounds, through a headset or throughexternal speakers, which are perceived by the user as coming from abovehim during the inspiratory phase and from below during the expiratoryphase. While many suitable techniques for generating three-dimensionalsound are known in the art in general, some preferred methods aredescribed in the above-cited article by Begault.

Reference is now made to FIGS. 13 and 15A. FIG. 15A is a graph,schematically illustrating fictitious blood pressure data of user 100,as recorded by device 120 during one or more sessions, in accordancewith a preferred embodiment of the present invention. It is known in theart that self-administered blood pressure measurements made outside of ahealthcare facility are often inaccurate and/or inconsistent, due toimproper placement of the blood pressure cuff, patient inexperience, orhighly-variable measurements conditions. For example, twosignificantly-different blood pressure measurements may be made onsuccessive days at exactly 9:00 AM, but may only reflect the fact thaton the second day, the user had just finished carrying groceries up aflight of steps. It is thus appreciated that blood pressure measurementsfor a particular user may vary substantially in successive measurementsmade during a single day or over many days or weeks. The inventor hasfound, however, that despite the large variation in blood pressure(e.g., from 110/70 to 160/90), there is a strong and typically linearcorrelation between the diastolic and the systolic measurements, as isshown in FIG. 15A. Some aspects of this correlation are described in theabove-cited abstract, entitled, “Repeated blood pressure measurementsmay probe directly an arterial property.”

Preferably, processor 122 calculates a regression line 250,Systolic=K ₁*Diastolic+K ₂,

or another statistical relationship which describes the generallocations of a substantial number of the points in FIG. 15A. If in asubsequent blood pressure measurement, a systolic-diastolic pairsubstantially deviate from the regression line (e.g., by greater thantwo standard deviations along the X-axis, Y-axis, or perpendicularly tothe regression line), then processor 122 identifies thesystolic-diastolic pair as being an outlier, and automatically actuatesblood pressure cuff 160 (FIG. 13) to make another blood pressuremeasurement. Two such outlier measurements are marked by squares in FIG.15A. Preferably, blood pressure taken over a representative period aretransmitted through data port 140 to a remote server, and the remoteserver prepares a report for presentation to the user or to his/herphysician. Alternatively, the user prints the report and brings it tothe physician at the next visit. Further preferably, the report does notcontain the blood pressure measurements that were considered outliers.Alternatively, all of the measurements are presented, and a square orother marker is placed around outliers. Preferably, the report containsa summary as well as detailed information, such that the informationtherein can be quickly and easily read by a medical professional.

In addition to or instead of the statistical analysis just described,processor 122 preferably compares two successive blood pressuremeasurements made during a relatively short time period (e.g., less than15 minutes), and automatically initiates a third blood pressuremeasurement if a function of the disparity between the first twomeasurements is greater than a threshold. According to one preferredprotocol, the systolic (or diastolic) pressure X₁ recorded at the firsttime is analyzed in combination with the systolic (or diastolic)pressure X₂ measured at the second time so as to evaluate the followinginequality:2*|X ₁ −X ₂ |/|X ₁ +X ₂|<0.1

If the inequality is true, then any disparity between the twomeasurements is not considered sufficiently large to label one or theother as suspect. In the event that the inequality is found to be false,however, the processor actuates blood pressure cuff 160 to make a thirdblood pressure measurement. Preferably, this third measurement isanalyzed in combination with the second measurement, to determinewhether the disparity therebetween is greater than the threshold.Alternatively, all three measurements are evaluated to determine whethertwo of them are sufficiently close to each other, and the remainingmeasurement diverges from the two close measurements. In this case, bothclose measurements are typically recorded, or the mean of the two closemeasurements is recorded. Alternatively or additionally, other methodsare employed to eliminate spurious blood pressure measurements. Thisprocess may continue until the inequality is satisfied, or untilindications are found that repeated measurements will not lead to areliable result, in which case the user is referred to technicalassistance (e.g., at the remote server).

Preferably, blood pressure measurements which are not found to bespurious are analyzed over a time period, typically ranging from days tomonths, so as to determine whether a parameter of the blood pressuremeasurements changes in a statistically-significant manner during thetime period. For example, the systolic and diastolic blood pressure maybe monitored to determine whether they demonstrate astatistically-significant drop over a three month period. Preferably, inits optimization of the parameters of an intervention strategy,processor 120 utilizes forms of statistical analysis that are describedherein or that would be obvious to a person skilled in the art uponreading this disclosure. Thus, in a sample case treating hypertension,during three consecutive three month periods P1, P2, and P3, havingrespective intervention protocols I1, I2, and I3, the user's meansystolic blood pressure may be found to be 160, 147, and 142,respectively. Prior art strategies, which typically include drugs,exercise, and/or relaxation techniques, would tend to favor interventionI3, because it yielded the lowest mean systolic blood pressure.According to this embodiment of the present invention, however, device120 is able to determine the statistical significance of the differencesbetween the results generated by each of the intervention protocols, andin some circumstances would choose intervention I2 as the optimum,rather than I3. This decision by processor 122 would occur incircumstances in which, for example, the mean systolic blood pressuredue to intervention I3 is not significantly smaller (p<0.05) than thatdue to intervention I1, while the blood pressure due to intervention I2is significantly smaller than that due to intervention I1.

It is the inventor's belief that there are no satisfactory methods orapparatus known in the art which accurately and reliably monitor theeffect of different intervention strategies on an the blood pressure ofan ambulatory patient, because self-administered blood pressuremeasurements are so frequently flawed, as described hereinabove, andbecause the costs associated with sufficiently frequent,professionally-administered blood pressure tests are prohibitive formost of the population. This embodiment of the present invention, bycontrast, preferably utilizes: (a) statistical analysis of bloodpressure data derived from self-administered blood pressuremeasurements, often including (b) the identification and rejection of alarge number of spurious measurements, which result from improper use ofthe blood pressure apparatus, so as to enable (c) reliable comparisonsof the results of various intervention protocols, based upon whichprocessor 122 can initiate (d) automated optimization of theintervention strategy.

FIG. 15B is a histogram, schematically illustrating fictitious bloodpressure data, as recorded by device 120 during two time periods P1 andP2, in accordance with a preferred embodiment of the present invention.It is the inventor's belief that the frequent measurements of bloodpressure provided by these embodiments of the present invention yield anadditional benefit which is generally not realized using methods andapparatus known in the art. In particular, these embodiments allowprocessor 122 and/or the user's physician to learn important informationbased on the distribution of blood pressure measurements (and/or otherphysiological measurements) taken during the various time periods inwhich the user operates device 120.

For example, as shown in FIG. 15B, processor 122 or the remote servermay generate two histograms showing, during respective time periods, thepercentage of systolic blood pressure measurements that were in each ofthe following ranges: 100-119, 120-139, 140-159, and 160-179. Theexcessively-high risk of stroke and other cardiovascular diseases knownto be associated with systolic pressure above 160 mm Hg suggests to theinventor that a significant reduction of blood pressure in this rangealone may contribute considerably to the user's health, even if the meanblood pressure is substantially unaffected. The inventor believes thateven if the mean systolic blood pressure value does not changesignificantly during two or more consecutive time periods,diagnostically-useful information may be obtained by analyzing shifts inthe histogram over time.

In particular, it is hypothesized that modifying the interventionprotocol so as to reduce the occurrence of systolic blood pressuremeasurements in the right-most column of the histogram (i.e., systolicreadings between 160 and 179) may be even more important than reducingthe mean systolic blood pressure. This hypothesis is based on theinventor's understanding that in some patients, a substantial portion ofthe negative effect of hypertension is caused by the intermittent timeperiods in which the blood pressure is at its highest values. Therefore,even if there were to be a rightward shift of the histogram at the lowerblood pressure levels, which would ostensibly be a negative result ofthe intervention, this would nevertheless be offset by a leftward shiftat higher blood pressure levels. It is noted that in clinical trialsusing embodiments of the present invention, therapies such as thosedescribed herein produce desired leftward shifts in the histogram bothat higher and at lower blood pressures.

FIG. 16 is a sample musical composition map, in accordance with apreferred embodiment of the present invention. The vertical (Y) axisshows musical notes, which are represented by piano keys extending fromoctave 3 to octave 7, and which are preferably coded according to theMusical Instrument Digital Interface (MIDI) protocol or another suitableprotocol. Individual musical notes in the composition are represented bysegments parallel to the horizontal (X) axis, the length of each segmentcorresponding to the duration of the respective note (e.g., whole, half,or quarter notes). The X-axis is divided into “musical units,” whichgenerally correspond to the measures of standard musical terminology.Each musical note is defined according to standard MIDI notation, asbeing played by a specified musical instrument, and belonging to aspecified “layer” of the output. Since the instruments are synthesizedsounds, many sound parameters (such as tempo, overall volume, the volumeof each individual layer, and envelope parameters, such as attack rate,decay rate, and echo) can be controlled using standard MIDI commands orother commands which control sound synthesizers.

The example shown in FIG. 16 includes two periods of music, each lastingfor four musical units—musical units 1-4 and 5-8. Musical units 1 and 5correspond to the inspiration phase, while units 2-4 and 6-8 correspondto expiration. Thus, FIG. 16 shows musical patterns corresponding to twocomplete respiratory cycles.

Unlike music composition software known in the art, music generatedaccording to some preferred embodiments of the present invention ischaracterized by the music being synchronized with respect to abiorhythmic signal—either to match the biorhythmic signal, or, if thesignal is too fast or too slow, to go slightly slower or faster than thesignal, respectively. Moreover, according to some preferred embodimentsof the present invention, the selection of which particular layers areto have their sound output at any given time is also determinedresponsive to the biorhythmic signal. For example, if the signal isfast, e.g., corresponding to breathing at 15 breaths per minute, thenpreferably a small number of layers will be played, or, alternatively,layers having slower notes will be played at the fast tempocorresponding to the respiration rate. In this way, a reasonable,pleasant number of notes will be played during each phase ofrespiration. However, as the user's respiration is guided by the musicto slow down, for example, to 6 breaths per minute, the same set oflayers would sound boring, because the total number of notes playedduring a given time period would be too low. Therefore, as the user'srespiration rate decreases, new layers are preferably turned on, whichwould cause the output of a reasonable number of notes per unit of time.

More specifically, in order to entrain the user's breathing, a basicmelody is preferably played in one of the layers, which can be easilyidentified by almost all users as corresponding to a particular phase ofrespiration. On top of the basic melody, additional layers are typicallyadded to make the music more interesting, to the extent required by thecurrent breathing rate, as described hereinabove. For example, duringthe inspiratory phase, the user's respiratory muscles need to developforces so as to draw in air. This period may be represented by a horn(layer #1), while expiration, which involves an effortless and passiverecoil of the rib cage, may be represented by the relaxing music of aflute (layer #2). Typically, the basic melody corresponding to thisbreathing includes musical cords, played continuously by the appropriateinstrument during each phase, as shown in FIG. 16. When eitherexpiration or inspiration extends for more than about two seconds,simple cords like these sound relatively boring. In particular, theratio of the duration of expiration to inspiration is typically greaterthan or equal to one, and is guided to increase as breathing becomesslower. Therefore, in order to keep the user interested in the breathingexercise, a third layer having guitar sounds is added to the first twolayers (horn and flute) when the duration of the expiratory phaseincreases above a predetermined threshold. As the duration of theexpiratory phase continues to increase, and crosses a second, higherthreshold, the guitar layer is silenced, and replaced by a fourth layer(e.g., piano), which has a larger number of musical notes.Alternatively, all four layers play simultaneously when the expiratoryphase is particularly long.

The inventor has found that in some applications, up to four layers aretypically needed in order to create music that sounds pleasant, so as toentrain breathing in the range of 3 to 30 breaths per minute. Thespecific choice of instrument(s) to include in each layer depends on thestyle of musical composition, as well as how it is perceived atdifferent breathing rates and inspiration/expiration ratios. Unlikestandard music composition theory known in the art, music as generatedby some embodiments of the present invention is somewhat more flexiblein its use of tempo and rhythm, even though typical listeners do notgenerally perceive the difference between the music generated by device120 and, for example, traditional easy-listening music.

In particular, music generation as practiced by these embodiments of thepresent invention differs from standard computer music composition (orhuman music composition) in that physiological rhythms are not usuallyrelated by integer multiples of durations, as will be described,whereas, for example, Western music principles essentially require musicto have a strictly-regulated rhythmic structure. The inventor has foundthat although unguided human respiration may have Expiration:Inspiration(E:I) ratios having any real value from 0.50 to 4.0, people do not enjoymusic in which, for example, the duration of one measure is 1.4 timesthe duration of the following measure. Therefore, for example, if it isdesired to change the E:I ratio from 1:2 to 4:1, the music typicallydoes not transition the user smoothly through the E:I ratios {4:8,4:7.8, 4:7.6, . . . , 4:1.2, 4:1}, as might be appropriate for arespiration unit which simply employs a blinking light. Instead, musicis preferably generated whose basic musical units (e.g., measures)nearly or exactly correspond to a sequence of integer E:I ratios thatgovern the user's inspiration and expiration, such as (in order): 1:2,2:3, 3:4, 1:1, 4:3, 3:2, 2:1, 3:1, and 4:1. It is noted that theinspiration or expiration phases would therefore have durations whichare integer multiples of a base duration. Alternatively, a simpler setof ratios are used, such as 1:2, 1:1, 2:1, 3:1, and 4:1.

For some applications, it is desirable to elongate slightly the lengthof one of the respiratory phases, typically, the expiration phase. Forexample, to achieve respiration which is 70% expiration and 30%inspiration, a musical composition written for an E:I ratio of 2:1 maybe played, but the expiration phase is extended by asubstantially-unnoticed 16%, so as to produce the desired respirationtiming. The expiration phase is typically extended either by slowingdown the tempo of the notes therein, or by extending the durations ofsome or all of the notes.

Preferably, although not necessarily, a set of pre-written musicalcompositions is stored in memory 124 (FIG. 13), corresponding to eachinteger ratio which may be used to guide the breathing of user 100. Forexample, memory 124 may contain one or more compositions correspondingto each of the ratios {i:j}, where i and j range from 1 to 4.Alternatively, substantially all of the music is written according to a4:1 structure, but the notes are composed such that that segments ofvarious lengths may be removed at the end of each musical unit, so as togenerate other integer ratios (e.g., 3:1, 2:1, 1:1), and such that themusic still sounds pleasant.

Although music for entraining breathing is described hereinabove asincluding two phases, it will be appreciated by persons skilled in theart that the music may similarly include other numbers of phases, asappropriate. For example, user 100 may be guided towards breathingaccording to a 1:2:1:3 pattern, corresponding to inspiration, breathholding (widely used in Yoga), expiration, and post-expiratory pause(rest state).

In a preferred embodiment, the volume of one or more of the layers ismodulated responsive to a respiration characteristic (e.g., inhalationdepth, or force), so as to direct the user to change the characteristic,or simply to enhance the user's connection to the music by reflectingtherein the respiration characteristic.

Alternatively or additionally, parameters of the sound by each of themusical instruments may be varied to increase the user's enjoyment. Forexample, during slow breathing, people tend to prefer to hear soundpatterns that have smoother structures than during fast breathing and/oraerobic exercise.

Further alternatively or additionally, random musical patterns and/ordigitized natural sounds (e.g., sounds of the ocean, rain, or wind) areadded as a decoration layer, especially for applications which directthe user into very slow breathing patterns. The inventor has found thatduring very slow breathing, it is desirable to remove the user's focusfrom temporal structures, particularly during expiration.

Still further alternatively or additionally, the remote server maintainsa musical library, to enable the user to download appropriate musicand/or music-generating patterns from the Internet into device 120.Often, as a user's health improves, the music protocols which wereinitially stored in the device are no longer optimal, so the userdownloads the new protocols, by means of which music is generated thatis more suitable for his new breathing training.

FIGS. 17A, 17B, and 17C are schematic illustrations of astress-detecting device 400, for sensing respiration of a user, inaccordance with a preferred embodiment of the present invention. FIG.17A is a cross-sectional view of the whole device, FIG. 17B is amagnified view of a central region of FIG. 17A, and FIG. 17C is aperspective view of a preferred implementation of device 400. For someapplications, device 400 is used as part of the sensor structuresdescribed in U.S. Pat. No. 5,423,328. It is noted that FIG. 17C showsdevice 400 according to an embodiment which is appropriate for massproduction and is relatively inexpensive to build.

Stress-detecting device 400 preferably includes a biorhythmic activitysensor 402, slidably disposed on a belt 404 worn by the user. Belt 404is preferably elastic and/or stretchable along at least a portion of itslength. Output signals of sensor 402 are preferably transferred tomonitoring apparatus such as device 120 (FIG. 13), either by wired orwireless communication. Alternatively, device 400 may be provided with adisplay (not shown), as described in U.S. Pat. No. 5,423,328.

Device 400 preferably comprises a deformable plate 406, constructed ofan elastic material, which is conductive on at least one large surfacethereof. The deformable plate is supported from below by platesupporters 408. In order to minimize friction, the position ofdeformable plate 406 is preferably not fixed by plate supporters 408.The stress of belt 404 is exerted on deformable plate 406 by means of abridge 410, which may be an integral part of the deformable plate 406 orseparate therefrom, and is preferably made of a low-friction material toallow the belt to slide easily thereon. A counter plate 412, preferablymade of a rigid material, is also conductive on at least one largesurface thereof. Typically, counter plate 412 is made of a rigid plasticinsulating material used in manufacturing printed circuit (PC) boards,where a surface thereof which is closer to deformable plate 406 hasprinted thereon a conductive layer 414. This layer preferably extends tothe opposite surface of counter plate 412 by means of a coatedthrough-hole 416, as is well known in the art of manufacturing PCboards. As shown in FIG. 17B, conductive layer 414 is preferably coveredby an insulating layer 418, which is a standard procedure in themanufacture of PC boards.

Together, conductive layer 414 and the conductive surface of deformableplate 406 effectively create the plates of a capacitor. The gap betweenthese plates is preferably filled with an insulating, dielectricmaterial and air, with properties of the insulating material selecteddepending on the expected extent of deformation of deformable plate 406.It is noted that, unlike most capacitive sensors known in the art whichproduce changes in capacitance responsive to deformation of an elasticdielectric, the capacitance of device 400 is substantially not dependenton the properties of the material which fills the gap.

Deformable plate 406 and counter plate 412 are preferably compressed andfixed by a fixing pin 420, widely used for that purpose in the massproduction of PC boards. Fixing pin 420 passes through holes 422 and 424in deformable plate 406 and counter plate 412, respectively, whilecreating electrical contact with the conductive surface of deformableplate 406 and a conducting surface preferably printed on the side ofcounter plate 412 opposite to conductive layer 414.

In a preferred embodiment, counter plate 412 forms a base for electroniccomponents and printed circuits 426, which are typically used to conveya signal indicative of the capacitance engendered by the proximity ofconductive layer 414 and the conductive surface of deformable plate 406.As appropriate, the signals may be transmitted wirelessly or via a cable428 to another device. Preferably, cable 428 is configured in a mannerso as not to mechanically load counter plate 412. Stress-detectingdevice 400 is typically, but not necessarily, powered by a battery or iscoupled to an external power source via cable 428.

Depending on the details of the construction of stress-detecting device400, deformable plate 406 and counter plate 412 are typically close toeach other and relatively loose when no stress is applied by belt 404 onbridge 410. Therefore, it is generally advantageous in these cases toincorporate insulating protrusions 430 into device 400, so as to controlthe position and/or relative motion of deformable plate 406 and counterplate 412 under no-stress conditions.

Preferably, bridge 410 is somewhat elastic, and may be inserted intosquare grooves 432 of deformable plate 406 (FIG. 17C), so that legs 434of the bridge slightly press deformable plate 406 from the counter plate412, which force is counteracted by a base 436 of the bridge.Preferably, electric contact between fixing pin 420 and conductive layer414 is avoided by discontinuing conductive layer 414 in the vicinity ofhole 424 (as shown in FIG. 17C).

Advantageously, stress-detecting device 400 displays a relatively largecapacitance at no-stress, due to the small gap between deformable plate406 and counter plate 412, which capacitance sharply decays as thestress increases. By selecting stainless steel as a material fordeformable plate 406, the range of stresses in the steel generated bybreathing movements yield small deformations of plate 406, whichnevertheless produce substantial changes in the capacitance of device400. Thus, the stress-detecting device is highly sensitive to even smallbreathing motions. By using the changes in capacitance to drive anoscillator, as will be understood by a person skilled in the art, a5-fold change in frequency can be achieved for a 2 cm² area ofdeformable plate 406, in typical conditions for monitoring breathingmovements. The inventor has found that stress-detecting device 400 isable to achieve a reproducible, nearly linear, frequency-to-stressrelation.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove and in the above-cited patents, patentapplications, and articles, as well as variations and modificationsthereof that are not in the prior art, which would occur to personsskilled in the art upon reading the foregoing description. For example,whereas measuring blood pressure is described hereinabove with respectto many preferred embodiments of the present invention, for some otherembodiments, other physiological parameters of the user may be measured,such as, for example, heart rate, blood oxygenation, or respiration.

Alternatively or additionally, while some preferred embodiments aredescribed hereinabove with respect to driving modifications of theuser's blood pressure or heart rate, in a preferred embodiment of thepresent invention, the rate, magnitude, and/or another aspect ofperistalsis is modified through the effects of music or anotherintervention as described hereinabove, mutatis mutandis. For thisembodiment, sensor (e.g., electrical or acoustic sensors) are preferablycoupled to a site in a vicinity of the user's gastrointestinal tract, soas to detect aspects of the peristalsis and to enable the processor tooptimize the applied intervention. Typically, but not necessarily, thisembodiment employs methods and apparatus described in the above-citedU.S. Pat. No. 5,690,691 to Chen, et al. and/or in the above-citedarticle by Gimondo and Mirk.

In addition, while many of the embodiments are described as generatingmusic or another output signal which guides the user to intentionallymodify an aspect of a voluntary action (e.g., breathing), for someapplications, the user semi-consciously or unconsciously modifies theaction. For example, as described hereinabove, many people unconsciouslyand effortlessly entrain their breathing, walking, or running to anoutside rhythmic stimulus, such as strongly-rhythmic music or even ablinking light. Similarly, some of these embodiments of the presentinvention may be applied to people who are not consciously attempting tocoordinate the voluntary action with the rhythm of the appliedintervention. Thus, for some applications, a user of some of theseembodiments may read, talk, eat, or even sleep, while one or moresensors are measuring respective physiological variables of the user,and an intervention such as is described herein is applied to the user.

It is also to be understood that whereas many embodiments of the presentinvention are described hereinabove with respect to treating a user'shypertension, the scope of the present invention includes applying anintervention (e.g., modifying the user's respiration) so as to treathypotension or other blood pressure disorders.

The invention claimed is:
 1. A method for facilitating improving healthof a user, comprising: receiving a first physiological variable, whichis indicative of a voluntary action of the user; receiving a secondphysiological variable, which is not entirely under the direct voluntarycontrol of the user; and responsive to the first and second variables,changing the second physiological variable in a desired manner, by usingcircuitry to direct the user to modify a parameter of the voluntaryaction, by generating an output signal, wherein receiving the first andsecond physiological variables comprises measuring respiration of theuser using a respiration sensor, and generating a respiration signal inresponse thereto.
 2. The method according to claim 1, wherein generatingthe output signal comprises generating the output signal so as tofacilitate a change in a condition of the user selected from the groupconsisting of: an improvement in congestive heart failure of the user,an improvement of a blood pressure disorder of the user, an improvementin asthma of the user, an improvement in cystic fibrosis of the user, anincrease in mechanical compliance of arteries of the user, and anincrease in oxygenation of tissue of the user, a reduction in excessivesympathetic activity of the user, a modification of peristaltic activityof the user, a modification of vasomotor activity of the user, anincrease of heart rate variability of the user, an increase of venousreturn to a heart of the user, a reduction of vasomotor tone of theuser, a reduction of airway resistance of the user, an increase ofendurance of an expiratory muscle of the user, an increase of blood flowin capillaries of the user, and a reduction of pain experienced by theuser.
 3. The method according to claim 1, wherein generating the outputsignal comprises generating a music signal.
 4. The method according toclaim 1, wherein generating the output signal comprises outputtingsounds.
 5. The method according to claim 1, wherein generating theoutput signal comprises displaying one or more patterns on a screen. 6.The method according to claim 1, wherein receiving the secondphysiological variable comprises deriving from the respiration signal avariable indicative of a flow characteristic of the user's respiration.7. The apparatus according to claim 1, wherein receiving the secondphysiological variable comprises deriving from the respiration signal avariable indicative of a stability of breathing of the user.
 8. Themethod according to claim 1, wherein receiving the first physiologicalvariable comprises deriving from the respiration signal a variableselected from the group consisting of: a respiration rate of the user,an inspiration time of the user, and an expiration time of the user. 9.The method according to claim 1, wherein receiving the secondphysiological variable comprises deriving from the respiration signal avariable that is indicative of a percentage of time spent by the user ina pathological breathing pattern.
 10. The method according to claim 1,wherein measuring the respiration comprises measuring a characteristicof the user's respiration and determining, responsive thereto, anindication of airway resistance of the user.
 11. The method according toclaim 1, wherein measuring the respiration comprises measuring acharacteristic of the user's respiration and determining, responsivethereto, a mechanical load against which the user breathes.
 12. Themethod according to claim 1, wherein generating the output signalcomprises: determining, responsive to the first physiological variable,a current value of an Expiratory : Inspiratory (E:I) ratio of the user;determining a desired final value of the E:I ratio; and generating theoutput signal so as to direct the user to vary the user's E:I ratio fromthe current value thereof, through one or more intermediate valuesthereof, to the desired final value.
 13. The method according to claim1, wherein generating the output signal comprises: determining,responsive to the first physiological variable, a current respirationrate of the user; determining a desired final respiration rate; andgenerating the output signal so as to direct the user to vary the user'srespiration rate from the current value thereof, through one or moreintermediate values thereof, to the desired final value.
 14. The methodaccording to claim 1, wherein generating the output signal comprises:determining, responsive to the first physiological variable, a currentvalue of an Expiratory:Inspiratory (E:I) ratio of the user, determininga desired final value of the E:I ratio; and generating the output signalso as to direct the user to vary the user's E:I ratio from the currentvalue thereof, through one or more intermediate values thereof, to thedesired final value, at generally the same time as directing the user tovary the respiration rate.
 15. Apparatus for facilitating improvinghealth of a user, comprising: a respiration sensor, adapted to generatea respiration signal in response to respiration of the user; andcircuitry, adapted to: receive the respiration signal from therespiration sensor, and derive therefrom: a first physiologicalvariable, which is indicative of a voluntary action of the user, and asecond physiological variable, which is not entirely under the directvoluntary control of the user, and responsive thereto, generate anoutput signal which directs the user to modify a parameter of thevoluntary action, such that the second physiological variable will bechanged in a desired manner.
 16. The apparatus according to claim 15,wherein the sensor is configured to derive the second physiologicalvariable from the respiration signal, by deriving from the respirationsignal a variable indicative of a flow characteristic of the user'srespiration.
 17. The apparatus according to claim 15, wherein the sensoris configured to derive the second physiological variable from therespiration signal, by deriving from the respiration signal a variableindicative of a stability of breathing of the user.
 18. Apparatusaccording to claim 15, wherein the circuitry is adapted to generate theoutput signal to direct the user to modify the parameter of thevoluntary action, so as to facilitate a change in a condition of theuser selected from the group consisting of: an improvement in congestiveheart failure of the user, treatment of a blood pressure disorder of theuser, an improvement in asthma of the user, an improvement in cysticfibrosis of the user, an increase in mechanical compliance of arteriesof the user, an increase in oxygenation of tissue of the user, areduction in excessive sympathetic activity of the user, a modificationof peristaltic activity of the user, a modification of vasomotoractivity of the user, an increase of heart rate variability of the user,an increase of venous return to a heart of the user, a reduction ofvasomotor tone of the user, a reduction of airway resistance of theuser, an increase of endurance of an expiratory muscle of the user, anincrease of blood flow in capillaries of the user, and a reduction ofpain experienced by the user.
 19. Apparatus according to claim 15, andcomprising a belt adapted to be placed around a torso of the user,wherein the respiration sensor is adapted to generate the respirationsignal responsive to a change in circumference of the torso. 20.Apparatus according to claim 15, further comprising a speaker, whereinthe circuitry is adapted to drive the speaker to generate music, so asto direct the user to modify the parameter of the voluntary action. 21.Apparatus according to claim 15, further comprising a speaker, whereinthe circuitry is adapted to drive the speaker to output sounds, so as todirect the user to modify the parameter of the voluntary action. 22.Apparatus according to claim 15, further comprising a screen, whereinthe circuitry is adapted to drive the screen to display one or morepatterns corresponding to the output signal, so as to direct the user tomodify the parameter of the voluntary action.
 23. Apparatus according toclaim 15, wherein the respiration sensor is adapted to measure acharacteristic of the user's respiration so as to facilitate adetermination of airway resistance of the user.
 24. Apparatus accordingto claim 15, wherein the respiration sensor is adapted to measure acharacteristic of the user's respiration so as to facilitate adetermination of a mechanical load against which the user breathes. 25.Apparatus according to claim 15, wherein the circuitry is adapted to:(a) determine, responsive to the first signal, a current value of anExpiratory: Inspiratory (E:I) ratio of the user, (b) determine a desiredfinal value of the E:I ratio, and (c) generate the output signal so asto direct the user to vary the user's E:I ratio from the current valuethereof, through one or more intermediate values thereof, to the desiredfinal value.
 26. Apparatus according to claim 15, wherein the circuitryis adapted to: (a) determine, responsive to the first signal, a currentrespiration rate of the user, (b) determine a desired final respirationrate, and (c) generate the output signal so as to direct the user tovary the user's respiration rate from the current value thereof, throughone or more intermediate values thereof, to the desired final value. 27.Apparatus according to claim 15, wherein the circuitry is adapted to:(a) determine, responsive to the first signal, a current value of anExpiratory: Inspiratory (E:I) ratio of the user, (b) determine a desiredfinal value of the E:I ratio, and (c) generate the output signal so asto direct the user to vary the user's E:I ratio from the current valuethereof, through one or more intermediate values thereof, to the desiredfinal value, at generally the same time as directing the user to varythe respiration rate.